Drug maker: AriBio

Latest trial phase: Ongoing Phase 3 trial

Next steps: Present some Phase 3 data in 2025 

New updates: No

Originally developed for erectile dysfunction, AR1001 is now in a 1,150-person Phase 3 trial for early Alzheimer’s. Initial results are expected later this year, with final results projected by 2027. At AAIC 2025, researchers presented data from a 210-person, 26-week-long Phase 2 trial, which showed that the drug failed to slow cognitive decline in patients with mild to moderate Alzheimer’s disease. However, patients who received the highest dose of the drug did show a reduction in certain blood biomarkers of Alzheimer’s — a sign that more research is warranted.

Drug maker: NewAmsterdam Pharma

Latest trial phase: Completed Phase 3 trial

Next steps: Not yet announced

New updates: Yes

Obicetrapib is a cholesterol drug developed for people who don’t respond well to other cholesterol-lowering  medications. In a 2,530-person randomized placebo-controlled Phase 3 trial of people with high levels of cholesterol, researchers saw obicetrapib also slowed the accumulation of some Alzheimer’s blood biomarkers. The effect was largest in people who carried two copies of the Alzheimer’s risk gene ApoE4. The company believes that the drug, in addition to treating high cholesterol, has a direct impact on the brain. However, the researchers did not test whether the drug actually slowed cognitive decline in the trial, so this potential benefit, for now, is hypothetical.

Drug maker: Novo Nordisk

Latest trial phase: Ongoing Phase 3 trial

Next steps: Results of the trial are expected this year

New updates: No

Some early studies suggested a class of diabetes drugs called GLP-1 agonists — which have been proven to also help people lose weight and reduce the risk of heart attacks or stroke — might protect against Parkinson’s, Alzheimer’s and other forms of dementia too.  Now, Novo Nordisk is testing semaglutide (Ozempic, Wegovy) in two large Phase 3 trials (each with 1,840 participants) for early Alzheimer’s. Results are expected by the end of 2025.

Latest trial phase: Failed Phase 2 trial

Next steps: N/A

New updates: Yes

Several studies have found a link between the cold sore virus HSV-1 and Alzheimer’s disease. At AAIC, researchers presented data from a 120-participant Phase 2 trial that tested whether an anti-viral drug called valacyclovir could slow cognitive decline. Alas, the drug failed to move the needle. Researchers concluded that the link between herpes and Alzheimer’s needs reconsideration.

Drug maker: Eisai and Biogen

Latest trial phase: Approved by the FDA

Next steps: Injectable version of the drug and two additional ongoing studies

New updates: Yes

In trials:

• The drug is being tested in the AHEAD 3-45 study to see if it could prevent Alzheimer’s disease in asymptomatic individuals with risk factors for the disease. Results are expected in 2028.
• The drug is also being tested in conjunction with an anti-tau antibody in a Phase 2 trial. The results are expected in 2027. 
• Phase 3 trial participants who are still taking the drug four years later continue to experience benefits.

On the market:

• The FDA will decide by August whether or not to approve an injectable version of Leqembi, which could be delivered at home.
• A lower dosage of Leqembi was greenlit in January, approved for people who have been taking it for more than 18 months.
• UK’s public health agency refused to pay for Leqembi, meaning patients will need to pay out-of-pocket.
• Data presented at AAIC shows that the rates of side effects in the real world are similar to those in clinical trials.

Drug maker: Eli Lilly

Latest trial phase: Approved by the FDA

Next steps: Multiple ongoing late-stage trials to test the drug in other populations and doses

New updates: Yes

In May, Australian regulators approved Kisunla despite rejecting Leqembi. In June, the UK’s health authority declined to pay for Kisunla while Australia approved the drug. That same month, the FDA also approved a new dosing regimen that could reduce the frequency of brain swelling. 

At AAIC, the company presented data showing that trial participants continued to benefit even after their amyloid plaques were cleared and were no longer taking Kisunla. There are also plans in place to test Kisunla as an Alzheimer’s prevention in people with Down syndrome (results expected in 2027).

Drug maker: Eli Lilly

Latest trial phase: Phase 3

Next steps: The company has filed an application to approve an injectable version of the drug

New updates: No

Four Phase 2/3 trials are underway to assess this antibody’s effects on early Alzheimer’s and prevention in people with genetic risk. First results are expected in 2026.

Drug maker: NK Gen Biotech

Latest trial phase: Completed Phase 1/2 trial. Phase 2 trial ongoing

Next steps: Completion of Phase 2 trial in 2025

New updates: No

Derived from patients’ own “natural killer” immune cells, infusion-based drug toculeucel is being tested for moderate Alzheimer’s. Following positive data from three participants in a Phase 1 trial (presented at the AD/PD conference in April), the company launched a 36-person Phase 2 trial, expected to conclude at the end of 2025. 

At AAIC, the company shared more Phase 1 data showing that the infused cells crossed the blood-brain barrier and entered the brain, leading to a reduction in cerebrospinal fluid biomarkers of Alzheimer’s.

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 AAIC, the company presented promising data from its 149-person phase 1/2 trial. The overall rates of ARIA are substantially lower than with Leqembi and Kisunla. Roche intends to start 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.

Latest trial phase: Phase 3 trial ongoing

Next steps: Results expected in 2025

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 this year.

Drug maker: Karuna Therapeutics

Latest trial phase: Two Phase 3 trials

Next steps: Completion of the first Phase 3 trial later this year

New updates: No

Last year, KarXT, became the first new drug approved for treating schizophrenia in the US since the 1950s. Karuna Therapeutics is testing the drug in two ongoing Phase 3 trials for Alzheimer’s-related psychosis. Results from the trials (with 380 and 400 participants respectively) are expected in 2025 and 2026.

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. In July, the company announced it completed enrollment for its ongoing 670-person Phase 3 trial. Safety and efficacy results are expected by mid-2026.