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Buntanetap for Alzheimer's Disease

Phase 2 & 3
Recruiting
Research Sponsored by Annovis Bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 1 day
Treatment 12 weeks
Follow Up 1 day
Awards & highlights

Summary

This trial tests buntanetap, a medication, on people with mild to moderate Alzheimer's disease. It aims to find out if different doses of the medication are effective and safe. Participants will take the medication daily for a few months, and their progress will be monitored through various assessments.

Who is the study for?
This trial is for people aged 55-85 with mild to moderate Alzheimer's, as per NIA criteria. They must have a study partner, be in good health without diseases affecting the study, and not at risk of self-harm. Women of childbearing age need a negative pregnancy test and agree to contraception; men must also agree to contraceptive measures.
What is being tested?
The trial tests Buntanetap's effectiveness and safety against a placebo in those with Alzheimer's over 12 weeks at home. Participants will undergo screening for up to 42 days before treatment starts, followed by four clinic visits and one phone call over approximately five months.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Buntanetap or the placebo during their treatment period which includes regular in-clinic visits.

Timeline

Screening ~ 1 day
Treatment ~ 12 weeks
Follow Up ~1 day
This trial's timeline: 1 day for screening, 12 weeks for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change
Secondary study objectives
Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale
Digital Symbol Substitution Test
Mini Mental State Examination Score

Side effects data

From 2022 Phase 1 & 2 trial • 75 Patients • NCT04524351
10%
procedural headache
10%
paraesthesia
10%
back pain
10%
headache
10%
constipation
10%
post lumbar puncture syndrome
10%
erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Posiphen, 40mg (Parkinson's Participants)
Posiphen, 20mg (Parkinson's Participants)
Posiphen, 10mg (Parkinson's Participants)
Posiphen, 80mg (Parkinson's Participants)
Posiphen, 5mg (Parkinson's Participants)
Placebo (Parkinson's Participants)
Placebo (Alzheimer's Participants)
Posiphen, 80mg (Alzheimer's Participants)

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 7.5mg BuntanetapExperimental Treatment1 Intervention
Buntanetap 7.5mg oral capsule with daily administration for a period of 12 weeks
Group II: 30mg BuntanetapExperimental Treatment1 Intervention
Buntanetap 30mg oral capsule with daily administration for a period of 12 weeks
Group III: 15mg BuntanetapExperimental Treatment1 Intervention
Buntanetap 15mg oral capsule with daily administration for a period of 12 weeks
Group IV: PlaceboPlacebo Group1 Intervention
Placebo oral capsule with daily administration for a period of 12 weeks

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby enhancing cholinergic function. NMDA receptor antagonists help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Buntanetap, similar to other investigational drugs, aims to inhibit the aggregation of amyloid-beta and tau proteins, which are believed to form toxic plaques and tangles in the brain, contributing to neuronal death and cognitive decline. This mechanism is crucial as it targets the underlying pathology of AD, potentially slowing disease progression and improving patient outcomes.

Find a Location

Who is running the clinical trial?

Annovis Bio Inc.Lead Sponsor
4 Previous Clinical Trials
621 Total Patients Enrolled

Media Library

Buntanetap (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05686044 — Phase 2 & 3
Alzheimer's Disease Research Study Groups: 15mg Buntanetap, 7.5mg Buntanetap, 30mg Buntanetap, Placebo
Alzheimer's Disease Clinical Trial 2023: Buntanetap Highlights & Side Effects. Trial Name: NCT05686044 — Phase 2 & 3
Buntanetap (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05686044 — Phase 2 & 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05686044 — Phase 2 & 3
~128 spots leftby Oct 2025