Alzheimer's Trial Watch: October 2025

A Record-Size Pipeline, With All the Complexity That Entails

The Alzheimer's drug development field entered 2025 with more experimental compounds in human testing than at any prior point in its history. The annual pipeline review by Cummings and colleagues, published in June 2025 in Alzheimer's & Dementia: Translational Research & Clinical Interventions ^[1], documented 182 active trials assessing 138 distinct drugs as of January 1, 2025. That includes 48 Phase 3 trials involving 31 drugs, 86 Phase 2 trials involving 75 drugs, and 48 Phase 1 trials testing 45 compounds across a widening range of biological targets ^[1].

The Phase 1 number deserves specific attention. In the 2024 pipeline, Phase 1 trials stood at 27. By the start of 2025, that count had reached 48, a 78% year-over-year increase reflecting accelerating early-stage investment and growing scientific confidence that targets beyond amyloid are worth pursuing systematically ^[1]. Twelve Phase 3 trials were projected to read out before the end of 2025, with 29 Phase 2 trials also scheduled to complete ^[1]. Combined, those active trials are running at more than 4,500 sites worldwide and require more than 50,000 participants to complete ^[1].

This edition of the Alzheimer's Trial Watch covers the most consequential milestones from the first three quarters of 2025: six programs that moved the research conversation this year, one high-profile failure that reframed a widely held hypothesis, and a diagnostic development that stands to change how sponsors identify and enroll trial participants going forward.

A note on sourcing: where milestones are based on company press releases or SEC filings, they are identified as such. A regulatory announcement or enrollment completion does not establish clinical efficacy, and peer-reviewed results are cited separately where available.

The Targets Have Diversified

Six years ago, anti-amyloid antibodies represented both the dominant hypothesis and the dominant investment thesis in Alzheimer's research. The 2025 pipeline tells a more varied story. Small molecule disease-targeted therapies now account for 43% of pipeline agents, with biological disease-targeted therapies comprising another 30% ^[1]. Repurposed drugs represent 33% of all pipeline agents, reflecting sustained effort to find therapeutic value in compounds with established safety profiles ^[1]. Cognitive enhancement programs account for 14% and neuropsychiatric symptom management for 11% ^[1].

Biomarkers now appear as primary outcomes in 27% of active trials ^[1]. That proportion was far lower in prior years. Its growth reflects a field that has learned from the failures of unselected populations in Phase 3 and is building eligibility criteria and outcome measures more carefully from the start. Sponsors designing new trials are increasingly anchoring enrollment to biomarker-confirmed pathology, which in turn creates new demands on site selection, screening infrastructure, and patient recruitment operations.

Six Programs That Shaped the Research Year

ALTITUDE-AD: Enrollment Closed Ahead of Schedule

Acumen Pharmaceuticals announced completion of enrollment in ALTITUDE-AD, its Phase 2 trial of sabirnetug (ACU193), on March 26, 2025, before the originally projected timeline ^[2]. Sabirnetug is a humanized monoclonal antibody targeting soluble amyloid beta oligomers (AβOs), a highly neurotoxic form of amyloid that binds to neurons, inhibits synaptic function, and drives neurodegeneration ^[2]. This target is distinct from the fibrillar amyloid plaques cleared by lecanemab and donanemab.

The trial enrolled approximately 540 individuals with early Alzheimer's disease, defined as mild cognitive impairment or mild dementia due to AD, across sites in the United States, Canada, the European Union, and the United Kingdom (NCT06335173) ^[2]. Sabirnetug is delivered by intravenous infusion once every four weeks, and the randomized, double-blind, placebo-controlled design evaluates its ability to slow cognitive and functional decline versus placebo ^[2]. Topline efficacy and safety data are expected in late 2026 ^[2].

Completing enrollment ahead of schedule in a 540-patient, multi-country Phase 2 program is not routine. Acumen attributed the milestone to significant interest from participants and investigators, and to the operational work of site teams across four countries ^[2]. Whether enrollment efficiency translates into positive efficacy data will not be known until 2026.

CT1812 (Zervimesine): A Sigma-2 Receptor Target Reaches a Regulatory Gate

Cognition Therapeutics announced completion of an End-of-Phase 2 meeting with the FDA on July 9, 2025, following the Phase 2 SHINE study of zervimesine (NCT03507790) in Alzheimer's disease ^[3]. SHINE enrolled 153 adults with mild-to-moderate AD and randomized participants to one of two oral daily doses (100 mg or 300 mg) or placebo for six months ^[3]. The study met its primary endpoints of safety and tolerability. Secondary assessments measured changes in cognition using ADAS-Cog 11 and MMSE, and in function using ADCS-ADL ^[3]. Approximately $30 million in National Institute on Aging grant funding supported the program ^[3].

Zervimesine (formerly CT1812) operates through a mechanism unrelated to amyloid clearance. It is a sigma-2 receptor antagonist designed to block the binding of amyloid beta oligomers to neuronal synaptic sites, protecting synaptic function without triggering the inflammatory response associated with antibody-mediated amyloid removal ^[3]. Because it is not an amyloid-clearing antibody, zervimesine is not expected to require the ARIA monitoring protocols that accompany that drug class; however, the full safety profile in larger populations remains to be established, and an investigational drug's label is not settled until regulatory review of Phase 3 data.

Cognition's announcement described the End-of-Phase 2 meeting as identifying a path forward for a Phase 3 program and a new drug application ^[3]. Per the company's own disclosure, formal FDA written minutes were expected in August 2025 to confirm the agreed development plan ^[3]. An aligned development path is a meaningful milestone; it is not the same as Phase 3 data.

ALZ-801 (Valiltramiprosate): A Missed Primary Endpoint and a 52% Subgroup Effect

Alzheon presented Phase 3 APOLLOE4 trial results for valiltramiprosate (ALZ-801) at the ADPD International Conference in Vienna in April 2025. The full peer-reviewed findings were published online September 28, 2025, and appeared in the November 2025 issue of the journal Drugs (doi: 10.1007/s40265-025-02250-5) ^[4].

The 78-week, randomized, double-blind, placebo-controlled trial specifically enrolled APOE4/4 homozygous patients, a population with high AD risk and limited access to anti-amyloid antibodies due to elevated ARIA risk ^[4]. On the primary endpoint (ADAS-Cog13) across the full trial population, valiltramiprosate did not achieve statistical significance ^[4].

The prespecified MCI subgroup, representing 39% of enrolled participants, produced a different result. In that subgroup, valiltramiprosate showed a 52% benefit on ADAS-Cog13 compared to placebo over 78 weeks, with treatment separation visible from week 13 ^[4]. Improvements in the Disability Assessment for Dementia were also statistically significant in the MCI population ^[4]. Readers should note this is a subgroup result from a trial that missed its primary endpoint; regulatory agencies typically require pre-specified subgroup hypotheses and replication in dedicated studies before drawing conclusions.

The safety profile was favorable throughout. Valiltramiprosate showed no increased risk of vasogenic brain edema in any dose group ^[4], a contrast to the boxed ARIA warning carried by approved anti-amyloid antibodies in APOE4 carriers. Valiltramiprosate is a prodrug of tramiprosate, formulated as an oral small molecule with improved pharmacokinetics and brain penetration. Its mechanism operates upstream of anti-amyloid antibodies by inhibiting the formation of soluble neurotoxic amyloid oligomers before plaque deposition is established, rather than clearing plaques that have already formed ^[4].

Lomecel-B (Laromestrocel): Cell Therapy Achieves First-in-Class Regulatory Status

Longeveron's laromestrocel (Lomecel-B) holds, to the company's knowledge, a distinction no other Alzheimer's therapy has yet achieved: it is the first cellular therapeutic candidate to receive FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer's disease ^[5]. RMAT designation was established under Section 3033 of the 21st Century Cures Act (Pub. L. 114-255) and provides access to intensive FDA guidance, early and frequent agency interactions, and eligibility for accelerated approval based on surrogate or intermediate endpoints ^{[5, 6]}.

Phase 2a CLEAR MIND trial data (NCT05233774), published in Nature Medicine (Rash BG et al., Nat Med 31:1257-1266, 2025) in March 2025, document the clinical evidence supporting continued development and FDA engagement ^[5]. The trial enrolled 49 participants across ten US centers (12 placebo; 13, 13, and 11 across three laromestrocel dose groups), with 48 completing treatment and analyzed for secondary and exploratory endpoints ^[5].

On volumetric MRI at 39 weeks, combined laromestrocel treatment groups (all three dose arms pooled) showed 48.4% slower progression of whole brain atrophy compared to placebo (P = 0.005; n = 32 treated vs n = 10 placebo) ^[5]. The two higher-dose groups individually showed reductions of up to 57% in whole brain atrophy (groups 3 and 4, P = 0.006 and P = 0.009) ^[5]. Left hippocampal atrophy was reduced by 62% in the combined treatment groups (P = 0.021), and bilateral hippocampal atrophy reductions were statistically significant for groups 2 and 3 (P = 0.029 and P = 0.028, respectively) ^[5]. The composite Alzheimer's Disease Score (CADS) secondary endpoint was met at the pre-specified significance threshold of P < 0.10 for group 2 versus placebo (P = 0.091) ^[5]. No infusion-related reactions, hypersensitivities, or ARIA events were reported ^[5].

Phase 2a results from a 49-patient trial at a single geographic cluster of sites should be interpreted as hypothesis-generating; they are not definitive evidence of efficacy without replication in larger, more diverse studies.

In March 2025, Longeveron announced a positive Type B meeting with the FDA, indicating alignment on study design, patient population, and endpoints for a planned pivotal Phase 2/3 trial ^[6]. Per the company's announcement, if positive, that single pivotal trial would support a Biological License Application (BLA) submission for Alzheimer's disease ^[6]. Trial initiation is anticipated in the second half of 2026, contingent on non-dilutive funding or a partnership arrangement ^[6]. Laromestrocel is derived from mesenchymal stem cells (MSCs) isolated from the bone marrow of healthy adult donors aged 18 to 45, with both RMAT and Fast Track designations held for the Alzheimer's program ^[5].

Intranasal Foralumab: A Single-Patient Case and a Phase 2a in Preparation

Tiziana Life Sciences produced two notable data releases in 2025 on intranasal foralumab, a fully human anti-CD3 monoclonal antibody being explored in Alzheimer's disease through nasal delivery. In May 2025, a peer-reviewed case report published in Clinical Nuclear Medicine documented TSPO-PET imaging findings in a 78-year-old patient with moderate AD treated under an FDA expanded access program ^[7]. After three months of intranasal foralumab, PET imaging showed a marked reduction in microglial activation in this single patient ^[7].

Both the potential and the limits of this result should be kept in perspective. Microglial overactivation is a recognized feature of neuroinflammation in Alzheimer's disease, and the PET finding was biologically plausible. However, a single-patient expanded-access case report cannot establish efficacy, dosing adequacy, or generalizability. It is preliminary evidence, not clinical proof.

In July 2025, Tiziana disclosed a transcriptional analysis of white blood cells from the same patient, documenting changes in CD4 cells, CD8 cells, and monocyte profiles following foralumab treatment ^[8]. Those immune cell shifts were consistent with the PET imaging findings and suggested a systemic regulatory immune response was associated with the observed change in central neuroinflammation ^[8]. The patient reported no adverse effects and elected to extend therapy ^[8].

Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development for intranasal delivery ^[7]. A Phase 2a trial in patients with mild AD was in preparation as of mid-2025, designed to evaluate foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies, using TSPO-PET imaging as a central endpoint ^[8].

T3D-959: Targeting Metabolism Rather Than Amyloid

T3D-959 is an oral, once-daily dual PPAR delta/gamma nuclear receptor agonist designed to address what its developers describe as neuro-metabolic dysfunction in Alzheimer's disease. The hypothesis is that insulin resistance and glucose metabolism impairment in the brain contribute to AD pathogenesis, and that restoring metabolic function may slow neurodegeneration ^[9].

The Phase 2 PIONEER trial produced results that supported advancing to Phase 2b/3, though the picture is more nuanced than company communications initially conveyed. A peer-reviewed analysis of the trial, published in January 2025 in the Alzheimer's & Dementia conference proceedings (DOI: 10.1002/alz.095625), reported data from a modified intent-to-treat (mITT) population of 141 patients ^[9a]. That mITT subset was derived from the original enrollment of 250 after investigators identified a cluster of sites with data irregularities, including patients assigned to active drug showing no detectable drug in plasma ^[9a]. In the mITT population, the ADAS-Cog11 primary endpoint in the 30 mg group approached but did not reach statistical significance (p = 0.073) ^[9a].

Within a subgroup of participants confirmed to have AD pathology by high pTau-217 ratio, those receiving 30 mg T3D-959 showed a numerically meaningful difference versus placebo on the ADAS-Cog11 at 24 weeks ^[9]. The original company press release described this as a 2-point improvement ^[9], reflecting the between-group difference; the full peer-reviewed data should be consulted for precise effect sizes and confidence intervals ^[9a]. The safety profile was clean: no drug-related ARIA events were reported ^[9].

According to the Alzheimer's Drug Discovery Foundation's drug profile for T3D-959, a Phase 2b/3 randomized, double-blind, placebo-controlled multicenter study has been planned for patients with biomarker-validated mild-to-moderate Alzheimer's disease, with trial initiation anticipated in 2026 ^[10]. The ADDF profile associates this planned study with identifier NCT06964230; direct ClinicalTrials.gov confirmation of that identifier was not available at the time of review. That trial will require biomarker-confirmed AD pathology at enrollment, a design change informed directly by the PIONEER experience.

The INVOKE-2 Failure: When Target Engagement Is Not Enough

Not all 2025 milestones were advances. Results from the INVOKE-2 trial of AL002, announced by Alector in November 2024, continued to shape research conversations throughout 2025 and were examined in depth in a peer-reviewed analysis published in Nature Medicine in July 2025 ^{[11, 12]}.

INVOKE-2 (NCT04592874) was a randomized, double-blind, placebo-controlled Phase 2 trial enrolling 381 patients with early Alzheimer's disease across centers in 11 countries ^[11]. AL002, developed by Alector in collaboration with AbbVie, is a TREM2-targeting agonistic monoclonal antibody. TREM2 is expressed on microglia and has been genetically linked to Alzheimer's risk through multiple large-scale genomic studies. The biological rationale was supported by substantial prior evidence.

Despite evidence of target engagement, AL002 failed to meet the primary endpoint of slowing clinical progression as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) ^[11]. There were no statistically significant treatment effects on any secondary clinical, functional, or biomarker endpoints, and amyloid PET imaging showed no treatment-related reduction in brain amyloid levels ^[11]. ARIA-related imaging abnormalities were identified, particularly in APOE4 homozygotes, who were subsequently excluded from continued enrollment ^[11]. Following the topline results, Alector discontinued the long-term extension study and reduced its workforce by 17% ^[11].

The Nature Medicine peer-reviewed analysis argued that INVOKE-2 does not definitively close the door on TREM2 as a therapeutic target ^[12]. It does, however, raise unresolved questions about the correct dose, timing, and patient population for any future TREM2-directed program ^[12]. The failure also illustrated a recurring pattern across Alzheimer's drug development: compelling genetic validation of a target does not predict that a therapeutic modulator of that target will produce measurable patient benefit at the dose and disease stage tested. INVOKE-2 achieved target engagement. Clinical efficacy did not follow.

The Blood Test That Changes How Trials Find Their Patients

The most operationally significant diagnostic development in Alzheimer's research in 2025 was not a drug. On May 16, 2025, the FDA cleared the first blood-based in-vitro diagnostic device to aid in diagnosing Alzheimer's disease: the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, developed by Fujirebio Diagnostics, Inc. ^[13]. Per the FDA's own clearance announcement, the test is intended for adult patients aged 55 years and older who are exhibiting signs and symptoms of the disease in a specialized care setting ^[13]. Labcorp launched the test nationally on August 18, 2025, making it available through more than 2,200 patient service centers across the United States ^[14].

The test measures the ratio of phosphorylated tau 217 to beta amyloid 1-42 in plasma, a ratio correlated with the presence or absence of amyloid plaques in the brain, reducing but not eliminating the need for amyloid PET ^[13]. In the multicenter clinical study of 499 patients that supported FDA clearance, 91.7% of individuals with a positive result had amyloid plaques confirmed by PET or CSF testing, and 97.3% of those with a negative result had a negative PET or CSF result ^{[13, 15]}. Fewer than 20% of the patients tested received an indeterminate result ^[13].

For clinical trial operations, those concordance numbers carry direct implications. A 97.3% negative agreement rate in the validation cohort means that very few candidates without amyloid pathology would pass an initial blood-based screen, which matters for programs where non-enriched populations have historically diluted treatment signals. Blood biomarker performance may also vary depending on the clinical setting, patient population, and prevalence of amyloid pathology in the screening pool, so test characteristics from the validation cohort may not translate directly to all trial-screening contexts. The test is not a standalone screening tool and must be interpreted alongside other clinical information ^[13]. Within those parameters, it removes two historically significant barriers: the lumbar puncture required for CSF biomarker testing, and the cost and access constraints associated with amyloid PET. For trial sites working to shorten screening timelines and reduce participant burden during eligibility confirmation, a blood draw is a meaningful operational substitution.

Program Snapshot: Six Trials at a Glance

Evidence maturity varies across these programs. "Peer-reviewed results" means at least one published journal article reports trial outcomes. "Enrollment complete; efficacy unknown" means only a company-announced operational milestone exists. "Phase 2b/3 pending" means a future trial is planned, not yet recruiting.

Six Alzheimer's programs, mechanisms, evidence maturity, and operational implications

What These Milestones Mean for Trial Teams

The 2025 Alzheimer's pipeline raises practical questions for everyone working inside AD drug development. Enrollment completion ahead of schedule in ALTITUDE-AD demonstrates what a well-prepared multi-country site network can achieve when biomarker-defined eligibility criteria are clear and site activation is thorough. The INVOKE-2 experience shows that clean execution is necessary but not sufficient: when the biological hypothesis is mismatched to the patient population or disease stage, rigorous trial conduct still produces a null result.

The pTau-217 blood test changes the calculus for eligibility screening. It does not eliminate the need for amyloid PET confirmation in all programs, but it provides a less invasive and more accessible first step that may reduce screen failure rates and shorten the path from referral to eligibility decision.

Programs that incorporate imaging-based outcomes like TSPO-PET, as in the foralumab program, place specific infrastructure demands on participating sites. Rater training, imaging protocols, and central read logistics all add operational complexity that affects site selection and budget planning. Similarly, the growing share of trials using biomarkers as primary outcomes (27% as of the 2025 pipeline review ^[1]) creates ongoing documentation and audit trail requirements at the site level that sponsors and monitors need to account for from protocol development onward.

The next 12 months will bring additional data points. Twelve Phase 3 trials were projected to complete in 2025 per the pipeline review ^[1], and late 2026 will bring topline results from ALTITUDE-AD. The zervimesine Phase 3 design, once formally confirmed through FDA minutes, will be a useful indicator of how sponsors are structuring biomarker-enriched enrollment and functional endpoint selection for a non-amyloid-clearing oral mechanism.

How Kitsa Fits Into This Picture

The Alzheimer's trial environment in 2025 places specific demands on site identification and patient matching. Programs targeting APOE4 homozygotes, biomarker-confirmed early MCI populations, or patients with active neuroinflammation each require a different site profile, different screening capabilities, and often different referral networks than a single-query feasibility approach can surface. KScout supports site identification and feasibility assessment using research network intelligence across Kitsa's clinical network. KScreener enables FHIR-connected patient pre-screening against study-specific eligibility criteria, including biomarker-defined inclusion and exclusion criteria, reducing the manual workload on site coordinators during periods of intensive screening. As Alzheimer's trial design continues to diversify in both mechanism and patient selection requirements, the operational value of precise site and patient matching grows alongside that diversity.

Key Takeaways

• The 2025 Alzheimer's drug development pipeline contains 182 trials and 138 drugs, including 48 Phase 1 trials, up 78% from the prior year, reflecting growing early-stage mechanistic investment ^[1].
• ALTITUDE-AD (sabirnetug/ACU193) completed enrollment of approximately 540 participants in March 2025, ahead of schedule across four countries; topline efficacy and safety data are expected in late 2026 ^[2].
• CT1812 (zervimesine) completed an End-of-Phase 2 FDA meeting in July 2025 following a Phase 2 SHINE study that met primary safety and tolerability endpoints; Phase 3 development plans await formal FDA written confirmation ^[3].
• ALZ-801 (valiltramiprosate) missed its overall primary endpoint in the APOLLOE4 Phase 3 trial, but a prespecified MCI subgroup (39% of participants) showed a 52% cognitive benefit over 78 weeks and no increase in vasogenic brain edema risk; subgroup results require cautious interpretation pending further investigation ^[4].
• Laromestrocel (Lomecel-B) is, to the company's knowledge, the first cellular therapeutic to receive FDA RMAT designation for Alzheimer's disease; CLEAR MIND Phase 2a data published in Nature Medicine showed 48.4% slower whole brain atrophy progression in combined treatment groups (P = 0.005) and up to 57% reduction in individual higher-dose arms, in a 49-patient trial ^[5].
• The Lumipulse G pTau-217/β-Amyloid 1-42 Plasma Ratio test received FDA clearance on May 16, 2025, for adults aged 55 and older with signs and symptoms of cognitive decline; in the 499-patient FDA-reviewed validation cohort, the test showed 91.7% positive agreement and 97.3% negative agreement with amyloid PET and CSF reference testing ^[13].
• AL002 failed in the INVOKE-2 Phase 2 trial in 381 patients across 11 countries despite target engagement, illustrating that genetic validation of a target and target engagement in the clinic are not sufficient to predict clinical efficacy ^[11].

This article is a clinical trial pipeline watch for informational purposes only and does not constitute clinical, regulatory, or investment advice. Trial results described here are drawn from company announcements, peer-reviewed publications, and regulatory sources as noted; readers should consult primary sources and qualified advisors for clinical or business decisions.

References

1. [1]Cummings J et al. "Alzheimer's disease drug development pipeline: 2025." Alzheimer's & Dementia: Translational Research & Clinical Interventions. June 2025. doi: 10.1002/trc2.70098. https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70098
2. [2]Acumen Pharmaceuticals. "Acumen Pharmaceuticals Completes Enrollment of ALTITUDE-AD, a Phase 2 Clinical Trial of Sabirnetug (ACU193) in Early Alzheimer's Disease." GlobeNewswire [press release]. March 26, 2025. ClinicalTrials.gov NCT06335173. https://www.globenewswire.com/news-release/2025/03/26/3049613/0/en/Acumen-Pharmaceuticals-Completes-Enrollment-of-ALTITUDE-AD-a-Phase-2-Clinical-Trial-of-Sabirnetug-ACU193-in-Early-Alzheimer-s-Disease.html
3. [3]Cognition Therapeutics. "Cognition Therapeutics Completes End-of-Phase 2 Meeting with FDA for Zervimesine (CT1812) in Alzheimer's Disease." GlobeNewswire [press release]. July 10, 2025. ClinicalTrials.gov NCT03507790. https://www.globenewswire.com/news-release/2025/07/10/3113149/0/en/Cognition-Therapeutics-Completes-End-of-Phase-2-Meeting-with-FDA-for-Zervimesine-CT1812-in-Alzheimer-s-Disease.html
4. [4]Abushakra S et al. "Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOEε4/ε4 Homozygotes with Early Alzheimer's Disease: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial." Drugs. 2025 Nov;85(11):1455-1472. doi: 10.1007/s40265-025-02250-5. ClinicalTrials.gov NCT04770220. https://clinicaltrials.gov/study/NCT04770220
5. [5]Rash BG et al. "Allogeneic mesenchymal stem cell therapy with laromestrocel in mild Alzheimer's disease: a randomized controlled phase 2a trial." Nature Medicine. Published March 10, 2025. doi: 10.1038/s41591-025-03559-0. ClinicalTrials.gov NCT05233774. https://www.nature.com/articles/s41591-025-03559-0
6. [6]Longeveron. "Longeveron Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-B) in Alzheimer's Disease." GlobeNewswire [press release]. March 20, 2025. 21st Century Cures Act, Pub. L. 114-255, Section 3033. https://www.globenewswire.com/news-release/2025/03/20/3046277/0/en/Longeveron-Announces-Positive-Type-B-Meeting-with-U-S--FDA-Regarding-Pathway-to-BLA-for-Laromestrocel-Lomecel-BTM-in-Alzheimer-s-Disease.html
7. [7]Singhal T et al. "Dampening of Microglial Activation with Nasal Foralumab Administration in Moderate Alzheimer's Disease Dementia." Clinical Nuclear Medicine. Published online May 13, 2025. doi: 10.1097/RLU.0000000000005955. https://doi.org/10.1097/RLU.0000000000005955
8. [8]Tiziana Life Sciences. "Tiziana Life Sciences Announces Immunologic Analysis of Nasal Foralumab in Moderate Alzheimer's Patient." SEC Form 6-K [corporate disclosure]. July 21, 2025. https://www.sec.gov/Archives/edgar/data/0001723069/000121390025065862/ea024966801ex99-1_tiziana.htm
9. [9]T3D Therapeutics. "T3D Therapeutics Announces Positive Top-Line Results from the Phase 2 PIONEER Trial of T3D-959 in Mild-To-Moderate Alzheimer's Disease." PR Newswire [press release]. November 3, 2023. https://www.prnewswire.com/news-releases/t3d-therapeutics-announces-positive-top-line-results-from-the-phase-2-pioneer-trial-of-t3d-959-in-mild-to-moderate-alzheimers-disease-301976115.html
10. [9a]Stanek J et al. "Phase 2 PIONEER Trial of Oral T3D-959 for the Treatment of Patients Diagnosed with Mild-to-Moderate Alzheimer's Disease: New Results in a Modified Intent-to-Treat Population." Alzheimer's & Dementia. Published January 9, 2025. doi: 10.1002/alz.095625. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11713541/
11. [10]Alzheimer's Drug Discovery Foundation (ADDF). "T3D-959 Cognitive Vitality Drug Profile." 2025. https://www.alzdiscovery.org/uploads/cognitive_vitality_media/T3D-959.pdf
12. [11]Alector. "Alector Announces Results from AL002 INVOKE-2 Phase 2 Trial in Individuals with Early Alzheimer's Disease and Provides Business Update." Alector Investor Relations [press release]. November 25, 2024. ClinicalTrials.gov NCT04592874. https://investors.alector.com/news-releases/news-release-details/alector-announces-results-al002-invoke-2-phase-2-trial
13. [12]Nature Medicine Correspondence. "Rethinking TREM2 as a target for Alzheimer's disease after the INVOKE-2 trial failure." Nature Medicine. July 2025. doi: 10.1038/s41591-025-03816-2. https://www.nature.com/articles/s41591-025-03816-2
14. [13]U.S. Food and Drug Administration. "FDA Clears First Blood Test Used in Diagnosing Alzheimer's Disease." FDA News Release. May 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease
15. [14]Labcorp. "Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease." PR Newswire [press release]. August 18, 2025. https://www.prnewswire.com/news-releases/labcorp-launches-first-fda-cleared-blood-test-for-alzheimers-disease-302531885.html
16. [15]Hu S et al. "The pTau217/Aβ1-42 plasma ratio: The first FDA-cleared blood biomarker test for diagnosis of Alzheimer's disease." Drug Discovery Ther. 2025;19(3):208-209. doi: 10.5582/ddt.2025.01055. PubMed PMID: 40582836. https://doi.org/10.5582/ddt.2025.01055