A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD

NCT06709014 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ANVS-25001
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 81

Brief Summary

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

Conditions

Early Alzheimers Disease

Keywords

Early Alzheimers disease; Early AD; AD; mild cognitive impairment; MCI; buntanetap; posiphen

Outcome Measures

Primary Outcomes (2)

• Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13)

  ADAS-Cog13 includes the original ADAS-Cog11 items that assess cognitive function across the memory, language, praxis, and orientation domains and adds a number cancellation task and a delayed free recall task. Total scores range from 0-85, with higher scores indicating greater cognitive impairment.

  From screening to 6-month readout, to end of treatment at 18 months.

• Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL)

  The Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL) is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's study partner to assess function to the degree to which the participant can perform a variety of tasks. The questionnaire asks 6 questions of basic ADLs and 17 instrumental ADLs. The iADL are more complex tasks, including activities such as shopping, maintaining appointments, or managing one's belongings or finances. The ADCS-iADL subset is assessed with items 6a and 7-23; scores range from 0 to 59, with lower scores indicating greater impairment in function.

  From screening to 6-month readout, to end of treatment at 18 months.

Study Arms (2)

buntanetap

EXPERIMENTAL

Drug: buntanetap/posiphen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

buntanetap/posiphen DRUG

30mg capsule by mouth once daily for 18 months

buntanetap

Placebo DRUG

Placebo capsule by mouth once daily for 18 months

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AD according to the 2024 National Institute on Aging and Alzheimer's Association criteria.
• Male or female, aged 55 - 85 years.
• MMSE 20-28 at screening and baseline.
• CDR global score=0.5 or 1, with memory box score at least 0.5 at screening and baseline.
• Positive for amyloid beta as defined by plasma p-tau217 level at screening.

You may not qualify if:

• 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.
• 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.
• 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,

Sponsors & Collaborators

• Annovis Bio Inc.: lead
• Prevail Infoworks: collaborator
• ProPharma Group: collaborator

Study Sites (81)

MD First Research

Chandler, Arizona, 85286, United States

RECRUITING

Xenoscience

Phoenix, Arizona, 85004, United States

RECRUITING

Clinical Endpoints

Scottsdale, Arizona, 85258, United States

RECRUITING

Advanced Research Center

Anaheim, California, 92805, United States

RECRUITING

Hope Clinical Research

Canoga Park, California, 91303, United States

RECRUITING

Sun Valley Research

Imperial, California, 92251, United States

RECRUITING

Mary S. Easton Center for Alzheimer's Research and Care, UCLA

Los Angeles, California, 90095, United States

RECRUITING

UC Davis Alzheimer's Disease Research Center

Sacramento, California, 95816, United States

RECRUITING

The Neuron Clinic

San Marcos, California, 92069, United States

RECRUITING

Mountain Neurological Center

Basalt, Colorado, 81621, United States

RECRUITING

CenExel Rocky Mountain

Englewood, Colorado, 80113, United States

RECRUITING

Research Center for Clinical Trials

Norwalk, Connecticut, 06851, United States

RECRUITING

Visionary Investigators Network

Aventura, Florida, 33180, United States

RECRUITING

SFM Clinical Research

Boca Raton, Florida, 33487, United States

RECRUITING

K2 Medical Research

Clermont, Florida, 34711, United States

RECRUITING

K2 Medical Research Daytona

Daytona Beach, Florida, 32114, United States

RECRUITING

Neuropsychiatric Research Center

Fort Myers, Florida, 33912, United States

RECRUITING

Velocity Clinical

Hallandale, Florida, 33009, United States

RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

ACTIVE NOT RECRUITING

K2 Medical Research

Lady Lake, Florida, 32159, United States

RECRUITING

Headlands Research JEM

Lake Worth, Florida, 33462, United States

RECRUITING

Accel Research Sites Lakeland (Alcanza)

Lakeland, Florida, 33803, United States

RECRUITING

K2 Medical Research

Maitland, Florida, 32751, United States

RECRUITING

ClinCloud Clinical Research

Melbourne, Florida, 32940, United States

RECRUITING

Flourish Research/Merritt Island Medical Research

Merritt Island, Florida, 32952, United States

RECRUITING

Miami Jewish Health

Miami, Florida, 33137, United States

RECRUITING

Aqualane Clinical Research

Naples, Florida, 34102, United States

RECRUITING

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

RECRUITING

Conquest Research

Orlando, Florida, 32832, United States

RECRUITING

Axiom Brain Health, LLC

Tampa, Florida, 33609, United States

RECRUITING

Conquest Research

Winter Park, Florida, 32789, United States

RECRUITING

Accel Neurosciences

Decatur, Georgia, 30030, United States

RECRUITING

CARE (Center for Advanced Research & Education)

Gainesville, Georgia, 30501, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

RECRUITING

Re:Cognition Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Charter Research Chicago

Chicago, Illinois, 60618, United States

RECRUITING

Great Lakes Clinical Trials/Flourish Research

Chicago, Illinois, 60640, United States

RECRUITING

Southern Illinois University

Springfield, Illinois, 62702, United States

RECRUITING

JWM Research

Indianaopolis, Indiana, 46256, United States

RECRUITING

Ascension via Christi Research

Wichita, Kansas, 37214, United States

RECRUITING

Tandem Intermediate

Metairie, Louisiana, 70006, United States

RECRUITING

Headlands Research Pharmasite

Pikesville, Maryland, 21208, United States

RECRUITING

Neurology Center of New England, PC

Foxborough, Massachusetts, 02035, United States

RECRUITING

Headlands Research Easter Massachusetts

Plymouth, Massachusetts, 02360, United States

RECRUITING

Mayflower Clinical

Russells Mills, Massachusetts, 02747, United States

RECRUITING

Elixia MA

Springfield, Massachusetts, 01103, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Precise Research Center

Flowood, Mississippi, 39232, United States

RECRUITING

Clinical Research Professionals - Headlands Research

Chesterfield, Missouri, 63005, United States

RECRUITING

Oasis Clinical Trials LLC

Las Vegas, Nevada, 89121, United States

RECRUITING

Cenexel Advanced Medical Research of New Jersey (AMRI)

Toms River, New Jersey, 08755, United States

RECRUITING

Advanced Clinical Institute

West Long Branch, New Jersey, 07764, United States

RECRUITING

Dent Neurologic Institute

Amherst, New York, 14226, United States

RECRUITING

SPRI

Brooklyn, New York, 11235, United States

RECRUITING

Neurological Associates of Long Island

Lake Success, New York, 11042, United States

RECRUITING

Parker Jewish Institute for Health Care and Rehab

New Hyde Park, New York, 11040, United States

ACTIVE NOT RECRUITING

New York Neurology Associates

New York, New York, 10003, United States

RECRUITING

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

RECRUITING

Ichor Research

Syracuse, New York, 13210, United States

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

AMC Research/Flourish Research

Matthews, North Carolina, 28105, United States

RECRUITING

Eximia Clinical Research

Raleigh, North Carolina, 27607, United States

ACTIVE NOT RECRUITING

American Clinical Research Center

Beavercreek, Ohio, 45432, United States

RECRUITING

Valley Medical Research

Centerville, Ohio, 45459, United States

RECRUITING

Insight Clinical Trials

Independence, Ohio, 44131, United States

RECRUITING

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Summit Headlands

Portland, Oregon, 97210, United States

RECRUITING

Suburban Research Associates

Media, Pennsylvania, 19063, United States

RECRUITING

K2 Keystone

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, 02914, United States

RECRUITING

Palmetto Primary Care & Specialty Physicians

Summerville, South Carolina, 29486, United States

RECRUITING

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

RECRUITING

K2 Medical Research Nashville

Nashville, Tennessee, 37204, United States

RECRUITING

Senior Adults Specialty Research

Austin, Texas, 78757, United States

RECRUITING

NeuroMind Clinical Trials

Houston, Texas, 77094, United States

RECRUITING

Central Texas Neurology Associates

Round Rock, Texas, 78681, United States

RECRUITING

Grayline Research Center

Wichita Falls, Texas, 76309, United States

RECRUITING

Memory Clinic, Inc.

Bennington, Vermont, 05201, United States

RECRUITING

Sana Research

Arlington, Virginia, 22205, United States

RECRUITING

Re:Cognition Fairfax

Fairfax, Virginia, 22031, United States

RECRUITING

Related Links

• Annovis Bio website

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

phenserine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Sarah MacCallum, BA, BSN

CONTACT

484-875-3192; maccallum@annovisbio.com

Alexander Morin, PhD

CONTACT

morin@annovisbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study partner will also be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2025-04

Locations

US (81)