Could buntanetap slow Alzheimer's? major trial underway

NCT ID NCT06709014

Disease control Sponsor: Annovis Bio Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily pill called buntanetap can help people with early Alzheimer's disease think more clearly and handle daily tasks better. About 760 adults aged 55-85 will take either the drug or a placebo for 18 months. Researchers will check memory, thinking, and safety through clinic visits and phone calls.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 760 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of AD according to the 2024 National Institute on Aging and Alzheimer's Association criteria. 2. Male or female, aged 55 - 85 years. 3. MMSE 20-28 at screening and baseline. 4. CDR global score=0.5 or 1, with memory box score at least 0.5 at screening and baseline. 5. Positive for amyloid beta as defined by plasma p-tau217 level at screening. 6. Neuroimaging (MRI) consistent with the clinical diagnosis of AD and without findings of significant exclusionary abnormalities (see exclusion criteria # 4). A historical MRI, up to 1 year prior to screening, may be used as long as there have been no interval clinical neurologic events that may suggest a change in the MRI scan. 7. Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant on study visits at designated times. 8. Female participants of childbearing potential\* must have a negative urine pregnancy test at screening, must be non-lactating and must agree to use a highly effective method of contraception (i.e., a method resulting in a failure rate of less than 1% per year when used consistently and correctly) during the trial and for one month after the last dose of trial treatment, such as: * Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation, * Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation, * Intrauterine device (IUD), * Intrauterine hormone-releasing system (IUS), * Bilateral tubal occlusion, * Vasectomized partner (a vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the participant. If not, an additional highly effective method of contraception should be used), * Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant). * Non-childbearing potential includes surgically sterilized or postmenopausal with no menstrual bleeding for at least one year prior to study start. 9. Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male participants must adopt a highly effective method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as: * Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation, * Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation, * IUD, * IUS, * Bilateral tubal occlusion. 10. General cognition and functional performance sufficiently preserved that the subject can provide written informed consent. At re-consent, a legally authorized representative may co-sign if participants do not meet the general cognition and functional performance needed in the opinion of the investigator. 11. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale. 12. Stability of permitted medications for at least 4 weeks prior to screening. Refer to Concomitant Medications section for details on prohibited and permitted medications. * Cholinesterase inhibitors and/or memantine medication, * Anticonvulsant medications used for epilepsy or mood stabilization, or neuropathic pain indications, and have not had a breakthrough seizure in 3 years prior to screening * Mood-stabilizing psychotropic agents including, but not limited to, lithium. 13. Adequate visual and hearing ability (physical ability to perform all the study assessments). 14. Participants previously exposed to buntanetap can still be included in the study after a 28-day wash out period. Exclusion Criteria: 1. Has a history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), unless they are stable on treatment or no longer need treatment. Mild depression or history of depression that is stable on treatment with selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI) or other anti-depression medication (e.g. Wellbutrin) at a stable dose is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications. 2. Has non-AD dementia, such as vascular dementia, Lewy body dementia, frontotemporal disease, PD dementia, B12 and thyroid deficiency caused dementia. 3. History of a seizure disorder, if stable on medication is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications. 4. Screening MRI (or historical MRI, if applicable) of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage (\>5) or infarct \> 1 cm3, \> 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess or brain tumor such as meningioma unless they are documented and stable). 5. Has a history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 450 ms for men and ≥ 460 ms for women ((in the absence of a bundle branch block), or torsades de pointes. 6. Has bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG at screening and deemed medically significant by the PI. 7. Has uncontrolled Type-1 or Type-2 diabetes. A participant with hemoglobin subunit alpha 1c (HbA1c) levels up to 7.5% can be enrolled if the PI believes the participant's diabetes is under control. 8. Has clinically significant renal (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<50 mL/min/BSA (body surface area) or hepatic impairment (alkaline phosphatase (ALP) \> 2.0 ULN and/or total bilirubin \> 2.0 ULN). 9. Has any clinically significant abnormal laboratory values. Participants with liver function tests (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) greater than twice the upper limit of normal will be excluded. 10. Is at imminent risk of self-harm, based on clinical interview and responses on the C- SSRS, or of harm to others in the opinion of the PI. Participants must be excluded if they report suicidal ideation with intent, with or without a plan or method (e.g., positive response to items 4 or 5 in assessment of suicidal ideation on the C-SSRS) in the past 2 months, or suicidal behavior in the past 6 months. 11. Has cancer or has had a malignant tumor within the past year, except participants who underwent potentially curative therapy with no evidence of recurrence (participants with stable untreated cancer are not excluded). 12. Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM. 13. Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. 14. Participants with learning disability or developmental delay. 15. Participants whom the PI deems to be otherwise ineligible. 16. Participants with a known allergy to the investigational drug or any of its components. Inactive ingredients of the investigational medicinal product: * Silicified Microcrystalline Cellulose * Dibasic Calcium Phosphate Dihydrate * Mannitol * Stearic Acid * Hypromellosee (capsule shells structure) * Titanium dioxide (opacifier of the capsule shells) 17. Participant is currently pregnant, breast-feeding, and/or lactating. 18. Participant is currently taking strong and moderate CYP3A4 inhibitors and/or inducers. Refer to Concomitant Medications section below for details on prohibited and permitted medications. 19. Participants with uncontrolled hypertension (systolic \>160mm Hg and/or diastolic \>95mm Hg) or hypotension (systolic \<90mm Hg and/or diastolic \<60 mm Hg) and deemed medically significant by the PI.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early alzheimers disease

Contacts and locations

Locations

AMC Research/Flourish Research

Matthews, North Carolina, 28105, United States
Accel Neurosciences

Decatur, Georgia, 30030, United States
Accel Research Sites Lakeland (Alcanza)

Lakeland, Florida, 33803, United States
Advanced Clinical Institute

West Long Branch, New Jersey, 07764, United States
Advanced Research Center

Anaheim, California, 92805, United States
American Clinical Research Center

Beavercreek, Ohio, 45432, United States
Aqualane Clinical Research

Naples, Florida, 34102, United States
Ascension via Christi Research

Wichita, Kansas, 37214, United States
Axiom Brain Health, LLC

Tampa, Florida, 33609, United States
CARE (Center for Advanced Research & Education)

Gainesville, Georgia, 30501, United States
CenExel Rocky Mountain

Englewood, Colorado, 80113, United States
Cenexel Advanced Medical Research of New Jersey (AMRI)

Toms River, New Jersey, 08755, United States
Central Texas Neurology Associates

Round Rock, Texas, 78681, United States
Charter Research Chicago

Chicago, Illinois, 60618, United States
ClinCloud Clinical Research

Melbourne, Florida, 32940, United States
Clinical Endpoints

Scottsdale, Arizona, 85258, United States
Clinical Research Professionals - Headlands Research

Chesterfield, Missouri, 63005, United States
Conquest Research

Orlando, Florida, 32832, United States
Conquest Research

Winter Park, Florida, 32789, United States
Dent Neurologic Institute

Amherst, New York, 14226, United States
Duke University

Durham, North Carolina, 27705, United States
Elixia MA

Springfield, Massachusetts, 01103, United States
Flourish Research/Merritt Island Medical Research

Merritt Island, Florida, 32952, United States
Grayline Research Center

Wichita Falls, Texas, 76309, United States
Great Lakes Clinical Trials/Flourish Research

Chicago, Illinois, 60640, United States
Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States
Headlands Research Easter Massachusetts

Plymouth, Massachusetts, 02360, United States
Headlands Research JEM

Lake Worth, Florida, 33462, United States
Headlands Research Pharmasite

Pikesville, Maryland, 21208, United States
Hope Clinical Research

Canoga Park, California, 91303, United States
Ichor Research

Syracuse, New York, 13210, United States
Insight Clinical Trials

Independence, Ohio, 44131, United States
JWM Research

Indianaopolis, Indiana, 46256, United States
Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States
K2 Keystone

Plymouth Meeting, Pennsylvania, 19462, United States
K2 Medical Research

Clermont, Florida, 34711, United States
K2 Medical Research

Lady Lake, Florida, 32159, United States
K2 Medical Research

Maitland, Florida, 32751, United States
K2 Medical Research Daytona

Daytona Beach, Florida, 32114, United States
K2 Medical Research Nashville

Nashville, Tennessee, 37204, United States
MD First Research

Chandler, Arizona, 85286, United States
Mary S. Easton Center for Alzheimer's Research and Care, UCLA

Los Angeles, California, 90095, United States
Mayflower Clinical

Russells Mills, Massachusetts, 02747, United States
Memory Clinic, Inc.

Bennington, Vermont, 05201, United States
Miami Jewish Health

Miami, Florida, 33137, United States
Mountain Neurological Center

Basalt, Colorado, 81621, United States
NeuroMind Clinical Trials

Houston, Texas, 77094, United States
Neurological Associates of Long Island

Lake Success, New York, 11042, United States
Neurology Center of New England, PC

Foxborough, Massachusetts, 02035, United States
Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States
Neuropsychiatric Research Center

Fort Myers, Florida, 33912, United States
New York Neurology Associates

New York, New York, 10003, United States
Oasis Clinical Trials LLC

Las Vegas, Nevada, 89121, United States
Palmetto Primary Care & Specialty Physicians

Summerville, South Carolina, 29486, United States
Precise Research Center

Flowood, Mississippi, 39232, United States
Quest Research Institute

Farmington Hills, Michigan, 48334, United States
Re:Cognition Chicago

Chicago, Illinois, 60611, United States
Re:Cognition Fairfax

Fairfax, Virginia, 22031, United States
Research Center for Clinical Trials

Norwalk, Connecticut, 06851, United States
Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, 02914, United States
Richmond Behavioral Associates

Staten Island, New York, 10314, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
SFM Clinical Research

Boca Raton, Florida, 33487, United States
SPRI

Brooklyn, New York, 11235, United States
Sana Research

Arlington, Virginia, 22205, United States
Senior Adults Specialty Research

Austin, Texas, 78757, United States
Southern Illinois University

Springfield, Illinois, 62702, United States
Suburban Research Associates

Media, Pennsylvania, 19063, United States
Summit Headlands

Portland, Oregon, 97210, United States
Sun Valley Research

Imperial, California, 92251, United States
Suncoast Clinical Research

New Port Richey, Florida, 34652, United States
Tandem Intermediate

Metairie, Louisiana, 70006, United States
The Neuron Clinic

San Marcos, California, 92069, United States
UC Davis Alzheimer's Disease Research Center

Sacramento, California, 95816, United States
Valley Medical Research

Centerville, Ohio, 45459, United States
Velocity Clinical

Hallandale, Florida, 33009, United States
Visionary Investigators Network

Aventura, Florida, 33180, United States
Xenoscience

Phoenix, Arizona, 85004, United States

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