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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 day1 visit
Treatment ~ 12 weeks3 visits
Follow Up ~ 1 day1 visit
Screening ~ 1 day
Treatment ~ 12 weeks
Follow Up ~1 day
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 • NCT0452435110%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the material used to make the capsule shells called hypromellose.You are allergic to titanium dioxide, which is used to make the capsule shells opaque.I'm sorry, but "Magnesium Stearate" is not a criterion in and of itself. Magnesium stearate is a common ingredient in many medications and supplements, and is generally considered safe for human consumption. It is often used as a lubricant or filler in pills and capsules. If you can provide me with more context, I can try to help you understand how magnesium stearate might be relevant to a specific clinical trial.You are taking cholinesterase inhibitors or memantine medication.You have had a problem with drugs or alcohol that was serious enough to be diagnosed by a doctor in the last 5 years.You have a condition that affects your ability to learn or develop normally.You are allergic to the investigational drug or any of its inactive ingredients.There is an ingredient called silicified microcrystalline cellulose in the study drug.You have not had thoughts of harming yourself or attempted suicide in the past two months or engaged in any suicidal behavior in the past six months, as determined by a medical professional using a standardized scale.You have a history of seizures, but it's okay if you're currently taking medicine and your condition is stable.You are taking medication to treat mood disorders, such as lithium.You have a history of severe mental illnesses such as schizophrenia, bipolar disorder or major depression according to the DSM criteria. However, mild depression that can be managed with a specific type of medication is allowed.You have a type of dementia that is not Alzheimer's disease, such as vascular dementia, Lewy body dementia, frontotemporal disease, Parkinson disease dementia, or dementia caused by vitamin B12 or thyroid deficiency.You have thoughts of hurting yourself or others, or have attempted suicide in the past 6 months.You are taking medication for epilepsy, mood stabilization or neuropathic pain.
Research Study Groups:
This trial has the following groups:- Group 1: 15mg Buntanetap
- Group 2: 7.5mg Buntanetap
- Group 3: 30mg Buntanetap
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05686044 — Phase 2 & 3
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