Trials Update:
September – December 2025
Latest news
Trials Tracker: 85 late-stage Alzheimer’s trials are currently recruiting.
What trials for Alzheimer's are happening right now?
What symptoms are drugs targeting?
Trials explainers
Biological targets of drugs being tested to treat cognitive symptoms
Treatments
Small molecule drugs for Alzheimer’s disease
Drug maker: AriBio
Latest trial phase: Ongoing Phase 3 trial
Next steps: Finish trial in 2026
New updates: No
Originally developed for erectile dysfunction, AR1001 is now in a 1,150-person Phase 3 trial for early Alzheimer’s. Final results are expected in 2026.
Drug maker: Anavex Life Sciences
Latest trial phase: Completed Phase 2/3 trial
Next steps: Committee voted against recommending approval in Europe
New updates: Yes
Blarcamesine is a small molecule drug that turns on a protein called the sigma-1 receptor in brain cells, which triggers a process called autophagy. Autophagy helps brain cells clear out brain build-ups of amyloid, tau, and other junk. In November, an expert committee recommended against approving the drug in Europe. The company has faced criticisms of its efficacy data and shareholder lawsuits alleging trial data misrepresentation. It has not filed for approval with the FDA. READ MORE.
Drug maker: Pharmatrophix
Latest trial phase: Shown safe and well-tolerated in Phase 2
Next steps: Unclear
New updates: Yes
LM11A-31 stimulates nerve growth and activates processes that prevent cell death. In an early Phase 2 trial in people with mild-to-moderate Alzheimer’s published last year, the drug appeared to reduce tau biomarkers but did not improve cognitive symptoms. While the company presented results at the recent CTAD conference, it did not announce a new trial.
Latest trial phase: Completed Phase 2 trial
Next steps: Not yet announced
New updates: Yes
S-adenosyl methionine (SAMe) is a molecule vital for maintaining brain health. Researchers speculated it might reduce tau levels in the brain, slowing cognitive decline. At CTAD, data from a 63-person, six-month Phase 2 trial showed that SAMe did not affect Alzheimer’s biomarkers or slow cognitive decline.
Drug maker: Novo Nordisk
Latest trial phase: Failed Phase 3 trial
Next steps: Analyzing data
New updates: Yes
Across electronic health records, people taking GLP-1 agonists, a class of diabetes and weight loss drugs, had a lower risk of Parkinson’s, Alzheimer’s and other forms of dementia. These findings convinced Novo Nordisk to test their GLP-1 drug, semaglutide, for early Alzheimer’s. Across two Phase 3 trials of more than 3,000 participants, semaglutide failed to slow cognitive decline. The company is still analyzing the data to determine next steps.
Drug maker: Spinogenix
Latest trial phase: Completed Phase 2 trial
Next steps: Unclear
New updates: Yes
Tazbetetol is a pill designed to help regenerate the connections between different brain cells. The company presented the data from its 24-person four week trial of mild-to-moderate Alzheimer’s. The results suggest the drug could boost cognitive and day-to-day function. The company has not yet announced a follow-up trial.
Latest trial phase: Failed Phase 2 trial
Next steps: N/A
New updates: Yes
Several studies have linked the cold sore virus HSV-1 to Alzheimer’s disease. Earlier this year, the antiviral drug valacyclovir that targets this virus failed to slow cognitive decline in a 120-person Phase 2 trial of early Alzheimer’s and mild cognitive impairment over 78 weeks. At CTAD, researchers presented data from a 50-person Phase 2 trial that showed no benefit for people with mild cognitive impairment. Researchers behind the trial say it’s time to reconsider the link between herpes and Alzheimer’s. READ MORE.
Drug maker: Cognition Therapeutics
Latest trial phase: Phase 3
Next steps: Initiating two Phase 3 trials
New updates: Yes
Zervimesine is a small molecule drug that helps clear toxic beta-amyloid proteins from the brain. At CTAD, its drugmaker Cognition Therapeutics announced plans to launch two six-month Phase 3 trials in mild-to-moderate Alzheimer’s. The company hasn’t finalized the design of the trials or started recruiting yet.
Antibodies, vaccines, cell infusions and more
Drug maker: Eisai and Biogen
Latest trial phase: Phase 2 and 3
Next steps: Completion of trials in late 2026/2027
New updates: Yes
Etalanetug is an anti-tau antibody. In a small early-stage trial of seven people with a genetic form of Alzheimer’s disease, the drug stopped more tau from forming and lowered the levels of tau biomarkers in the cerebrospinal fluid and blood. The drug is also being tested alongside anti-amyloid drug Leqembi across two different trials. READ MORE.
Drug maker: Eli Lilly
Latest trial phase: Approved by the FDA
Next steps: Ongoing studies to assess long-term impact
New updates: Yes
At CTAD, Eli Lilly showed that people who completed treatment with Kisunla continued to benefit. Beta-amyloid levels remained low two years after they stopped taking the anti-amyloid drug.
Drug maker: Eisai and Biogen
Latest trial phase: Approved by the FDA
Next steps: Ongoing studies to assess long-term impact
New updates: Yes
At CTAD, Eisai presented data comparing the cognitive trajectories of people taking Leqembi to the expected rate of decline in Alzheimer’s. The drug slowed progression by two to six years in the early stages. Results from another study confirmed the injectable form, approved for maintenance after 18 months of infusions, is safe and well tolerated.
Drug maker: Johnson & Johnson
Latest trial phase: Failed Phase 2 trial
Next steps: Discontinued
New updates: Yes
Johnson & Johnson’s anti-tau antibody posdinemab was discontinued after it failed to slow cognitive decline in a 500-person Phase 2 trial.
Drug maker: Roche
Latest trial phase: Completed Phase 1/2 trial
Next steps: The company is planning a Phase 3 trial
New updates: Yes
Roche’s anti-amyloid drug trontinemab “tricks” the blood-brain barrier to get into the brain more easily. As a result, it is administered at lower doses and clears beta-amyloid plaques faster.
At CTAD, the company presented promising data from its 149-person phase 1/2 trial. The high dose of the drug cleared out most beta-amyloid plaques in 92 percent of the participants. The overall rates of ARIA are substantially lower than with Leqembi and Kisunla. Roche has started recruiting for two large Phase 3 trials across 18 countries, testing trontinemab in MCI and early Alzheimer’s, later this year.
Roche is also planning a future trial of trontinemab to see if it could prevent Alzheimer’s in people without symptoms. READ MORE.
Drug maker: Novartis Pharma
Latest trial phase: Phase 2 trial
Next steps: Trial completing in 2028
New updates: Yes
VHB937 is an antibody drug that targets the brain’s immune cells, the microglia. It binds to a protein on the surface of these cells called TREM2, priming the microglia to protect against inflammation and clear out beta-amyloid plaques. Results for the 760-person trial are expected in 2028.
Drug maker: INmune Bio
Latest trial phase: Completed Phase 2 trial
Next steps: Unclear
New updates: Yes
INmune Bio’s drug XPro1595 works differently from other biologics developed for Alzheimer’s. Rather than targeting beta-amyloid or tau directly, it neutralizes a pro-inflammatory protein called TNF. In a 200-person Phase 2 trial of Alzheimer’s, the drug failed to slow cognitive decline in early Alzheimer’s. However, a subgroup of participants who had beta-amyloid plaques as well as high levels of inflammation may benefit. The company is speaking with regulators about next steps.
Small-molecule drugs for cognitive symptoms
Latest trial phase: Failed to show benefit in Phase 3
Next steps: Unclear
New updates: Yes
In Alzheimer’s, the parts of the brain that produce the neurochemical noradrenaline, which is important for thinking and cognition, die off. At CTAD, researchers presented data from a 148-person Phase 3 trial to see if guanfacine, which mimics noradrenaline, could provide a boost when combined with existing symptom-treating cholinesterase inhibitors. Unfortunately, adding on guanfacine had no effect on cognitive ability, psychiatric symptoms or day-to-day function.
Drug maker: Karuna Therapeutics, Bristol Myers Squibb
Latest trial phase: Four Phase 3 trials
Next steps: Completion of the first Phase 3 trial next year
New updates: Yes
Last year, KarXT, became the first new drug approved for treating schizophrenia in the US since the 1950s. The drug activates the same pathways in the brain as the neurochemical acetylcholine, which is crucial for memory and cognition. Since the brain isn’t producing enough acetylcholine in Alzheimer’s, drugmakers speculate that KarXT could help it compensate. Drugmakers are testing it across four phase 3 trials to assess its effects on agitation, psychosis and cognitive symptoms. Trials will finish between 2026 to 2028.
Drug maker: Neurim Pharmaceuticals Ltd
Latest trial phase: Completed Phase 2/3 trial
Next steps: Presenting data
New updates: No
Originally developed for sleep disorders, piromelatine may offer cognitive benefits to certain people with mild Alzheimer’s. Results from Neurim Pharmaceuticals’ Phase 2/3 trial which was completed earlier this year have not been presented by the company.
Latest trial phase: Phase 3 trial ongoing
Next steps: Results expected in 2026
New updates: No
An ongoing 348-person trial in Italy is exploring whether combining rotigotine (a Parkinson’s drug that affects the levels of a brain signaling molecule called dopamine) with an already-approved cholinesterase drug can improve cognition in people with mild to moderate Alzheimer’s. The trial is expected to finish next year.
Small-molecule drugs for psychiatric symptoms
Drug maker: IGC Pharma
Latest trial phase: Ongoing Phase 2 trial
Next steps: Completion of Phase 2 trial
New updates: No
In a 164-person Phase 2 trial, this oral, cannabinoid-based agitation drug showed slight improvements at six weeks, but more research is needed to determine efficacy. The trial concludes in 2026.
Medical devices
Device maker: Cognito Therapeutics
Latest trial phase: Ongoing Phase 3 trial
Next steps: Completion of Phase 3 trial in 2026
New updates: Yes
Last year, Cognito announced that its brain-stimulating light-and-sound headset, Spectris, showed lasting effects on brain volume and daily functioning in a preliminary study. At CTAD, the company presented more biomarker data suggesting the treatment may affect Alzheimer’s biomarkers in the cerebrospinal fluid. Safety and efficacy results from its 670-person Phase 3 trial are expected by mid-2026.



