Buntanetap for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Annovis Bio Inc.

Must be taking: Cholinesterase inhibitors, Memantine

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: Schizophrenia, Bipolar, Major depression, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are: * Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13? * Does buntanetap/Posiphen improve function as measured by ADCS-iADL? * What medical issues do participants have, if any, when taking buntanetap/Posiphen? Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease. Participants will: * Take buntanetap/Posiphen or a placebo every day for 18 months * Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18 * Complete pre- and post-clinic visit phone calls

Will I have to stop taking my current medications?

The trial requires that your current medications be stable for at least 4 weeks before starting. Some medications are allowed, like cholinesterase inhibitors and certain mood stabilizers, but strong CYP3A4 inhibitors or inducers are not permitted. Check with the trial team to see if your specific medications are allowed.

Eligibility Criteria

Adults aged 55-85 with early Alzheimer's Disease (AD) can join this trial. They must have an MMSE score of 21-28, a specific CDR score indicating memory issues, and MRI results consistent with AD. Participants need to show amyloid beta presence in their blood.

Inclusion Criteria

My MRI results are consistent with Alzheimer's and don't show major unrelated issues.

I am between 55 and 85 years old.

My mental state score is between 21 and 28.

+3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants take buntanetap/Posiphen or a placebo every day for 18 months

18 months

8 visits (in-person) at enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Participant Groups

The trial is testing buntanetap/Posiphen's effectiveness on improving cognition and daily function in early AD patients compared to a placebo. It involves taking the drug or placebo for 18 months with regular clinic visits and calls for checkups and tests.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: buntanetapExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention