Buntanetap for Alzheimer's Disease

Recruiting at 91 trial locations

Overseen By Gregory Kirk, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

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) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 18 months

760 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new drug, buntanetap (also known as Posiphen), is effective and safe for treating early Alzheimer's disease. Researchers seek to assess whether it improves thinking skills and daily functioning compared to a placebo (a look-alike substance with no drug). Participants will take either buntanetap or a placebo daily for 18 months, with regular clinic visits for tests and checkups. Suitable candidates have early Alzheimer's, confirmed by a specific diagnosis, and noticeable memory issues. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

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.

Is there any evidence suggesting that buntanetap is likely to be safe for humans?

Research has shown that buntanetap is generally safe and well tolerated in people with Alzheimer's and Parkinson's diseases. Studies have used doses up to 80 mg per day without major problems. No signs have indicated that the body struggles to handle the drug, even at higher doses. Additionally, a recent trial received a positive safety review, as experts examined the data and found no serious safety concerns. These findings suggest that buntanetap may be safe for humans, but ongoing studies aim to provide more evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Buntanetap is unique because it targets multiple neurotoxic proteins that are believed to play a role in Alzheimer's disease, which is different from many existing treatments like donepezil or memantine that primarily focus on symptom management. Most current treatments aim to enhance neurotransmitter activity to temporarily improve symptoms, but Buntanetap works by potentially slowing disease progression at the molecular level. Researchers are excited about Buntanetap because it offers a novel approach that could alter the course of the disease, addressing the underlying pathologies rather than just alleviating symptoms.

What evidence suggests that buntanetap might be an effective treatment for Alzheimer's disease?

Research has shown that buntanetap, which participants in this trial may receive, offers promising results for treating early Alzheimer's disease. In earlier studies, buntanetap improved memory and thinking skills, as measured by tests like ADAS-Cog13. It also enhanced the ability to perform daily tasks, as demonstrated by the ADCS-iADL test. The treatment was safe and well-tolerated, working effectively regardless of genetic factors such as the APOE4 gene, which is linked to Alzheimer's risk. Overall, buntanetap has proven to be both safe and effective in improving symptoms of early Alzheimer's. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Buntanetap

Trial Overview 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.

How Is the Trial Designed?

Group I: buntanetap Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Annovis Bio Inc.

Lead Sponsor

Trials

6

Recruited

1,700+

Prevail Infoworks, Inc

Collaborator

Trials

4

Recruited

1,000+

Prevail Infoworks

Industry Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36641607/

Buntanetap, a Novel Translational Inhibitor of Multiple ... Conclusions: Buntanetap is well tolerated and safe at doses up to 80mg QD in both AD and PD patients. Cmax and AUC increase with dose without evidence for a ...

2. annovisbio.com annovisbio.com/press-release/annovis-bio-announces-statistically-significant-phase-ii-iii-data-in-patients-with-early-alzheimers-disease

Annovis Bio Announces Statistically Significant Phase II/III ... Data presented in Figures 1, 2 and Table 1 demonstrate the efficacy of buntanetap in early AD patients. Other Study Endpoints. ADCS-CGIC This ...

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.074275

Interim Analysis Results of Buntanetap in Phase 3 Clinical ... Conclusion. Our phase2 data support that buntanetap is safe, well-tolerated, and efficacious in both AD and PD population. The interim analysis ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05686044

NCT05686044 | A Dose-ranging Study to Investigate ... The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild ...

5. alzheimersnewstoday.com alzheimersnewstoday.com/news/buntanetap-found-effective-safe-early-alzheimers-trial-data/

Buntanetap found effective, safe in early Alzheimer's trial The safety and efficacy of buntanetap therapy are comparable in early Alzheimer's patients regardless of APOE4 status, per new trial data.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06709014

NCT06709014 | A Double-blind Dual Study Assessing ... The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724002462

Buntanetap, a Novel Translational Inhibitor of Multiple ... Buntanetap is well tolerated and safe at doses up to 80mg QD in both AD and PD patients. Cmax and AUC increase with dose without evidence for a plateau up to ...

8. annovisbio.com annovisbio.com/press-release/annovis-bio-receives-excellent-safety-rating-and-positive-recommendation-to-continue-phase-iii-trial-of-buntanetap-for-parkinsons-disease-patients-from-the-independent-data-and-safety-monitoring-board-dsmb

Annovis Bio Receives Excellent Safety Rating and Positive ... Annovis Bio, Inc. (NYSE: ANVS), announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase III trial of buntanetap.

9. neurologylive.com neurologylive.com/view/fda-accepts-amended-protocol-phase-3-trial-buntanetap-alzheimer-disease

FDA Accepts Amended Protocol for Phase 3 Trial of ... Phase 2/3 data revealed buntanetap improved cognitive scores in patients with Alzheimer disease, with the highest dose (30 mg) showing a 3 ...