RecruitingPhase 3NCT06709014

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

A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

Sponsor

Annovis Bio Inc.

Enrollment

760 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Early Alzheimers Disease

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

Eligibility

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called buntanetap in people with early-stage Alzheimer's disease to see if it slows down memory decline and brain changes associated with the disease. **You may be eligible if...** - You are between 55 and 85 years old - You have been diagnosed with Alzheimer's disease according to current medical standards - Your memory and thinking abilities show mild impairment (MMSE score between 20-28) - You have a positive test for the amyloid beta protein associated with Alzheimer's - Your brain MRI is consistent with Alzheimer's disease - You have a study partner who sees you regularly and can participate in study visits **You may NOT be eligible if...** - Your memory impairment is severe (MMSE below 20) - Your cognitive decline is caused by another condition (e.g., other dementias) - You have brain MRI findings inconsistent with Alzheimer's - You are taking medications that interfere with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGbuntanetap/posiphen

30mg capsule by mouth once daily for 18 months

DRUGPlacebo

Placebo capsule by mouth once daily for 18 months

Locations(81)

MD First Research

Chandler, Arizona, United States

Xenoscience

Phoenix, Arizona, United States

Clinical Endpoints

Scottsdale, Arizona, United States

Advanced Research Center

Anaheim, California, United States

Hope Clinical Research

Canoga Park, California, United States

Sun Valley Research

Imperial, California, United States

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

Los Angeles, California, United States

UC Davis Alzheimer's Disease Research Center

Sacramento, California, United States

The Neuron Clinic

San Marcos, California, United States

Mountain Neurological Center

Basalt, Colorado, United States

CenExel Rocky Mountain

Englewood, Colorado, United States

Research Center for Clinical Trials

Norwalk, Connecticut, United States

Visionary Investigators Network

Aventura, Florida, United States

SFM Clinical Research

Boca Raton, Florida, United States

K2 Medical Research

Clermont, Florida, United States

K2 Medical Research Daytona

Daytona Beach, Florida, United States

Neuropsychiatric Research Center

Fort Myers, Florida, United States

Velocity Clinical

Hallandale, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

K2 Medical Research

Lady Lake, Florida, United States

Headlands Research JEM

Lake Worth, Florida, United States

Accel Research Sites Lakeland (Alcanza)

Lakeland, Florida, United States

K2 Medical Research

Maitland, Florida, United States

ClinCloud Clinical Research

Melbourne, Florida, United States

Flourish Research/Merritt Island Medical Research

Merritt Island, Florida, United States

Miami Jewish Health

Miami, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Suncoast Clinical Research

New Port Richey, Florida, United States

Conquest Research

Orlando, Florida, United States

Axiom Brain Health, LLC

Tampa, Florida, United States

Conquest Research

Winter Park, Florida, United States

Accel Neurosciences

Decatur, Georgia, United States

CARE (Center for Advanced Research & Education)

Gainesville, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Re:Cognition Chicago

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Charter Research Chicago

Chicago, Illinois, United States

Great Lakes Clinical Trials/Flourish Research

Chicago, Illinois, United States

Southern Illinois University

Springfield, Illinois, United States

JWM Research

Indianaopolis, Indiana, United States

Ascension via Christi Research

Wichita, Kansas, United States

Tandem Intermediate

Metairie, Louisiana, United States

Headlands Research Pharmasite

Pikesville, Maryland, United States

Neurology Center of New England, PC

Foxborough, Massachusetts, United States

Headlands Research Easter Massachusetts

Plymouth, Massachusetts, United States

Mayflower Clinical

Russells Mills, Massachusetts, United States

Elixia MA

Springfield, Massachusetts, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Precise Research Center

Flowood, Mississippi, United States

Clinical Research Professionals - Headlands Research

Chesterfield, Missouri, United States

Oasis Clinical Trials LLC

Las Vegas, Nevada, United States

Cenexel Advanced Medical Research of New Jersey (AMRI)

Toms River, New Jersey, United States

Advanced Clinical Institute

West Long Branch, New Jersey, United States

Dent Neurologic Institute

Amherst, New York, United States

SPRI

Brooklyn, New York, United States

Neurological Associates of Long Island

Lake Success, New York, United States

Parker Jewish Institute for Health Care and Rehab

New Hyde Park, New York, United States

New York Neurology Associates

New York, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Ichor Research

Syracuse, New York, United States

Duke University

Durham, North Carolina, United States

AMC Research/Flourish Research

Matthews, North Carolina, United States

Eximia Clinical Research

Raleigh, North Carolina, United States

American Clinical Research Center

Beavercreek, Ohio, United States

Valley Medical Research

Centerville, Ohio, United States

Insight Clinical Trials

Independence, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Summit Headlands

Portland, Oregon, United States

Suburban Research Associates

Media, Pennsylvania, United States

K2 Keystone

Plymouth Meeting, Pennsylvania, United States

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, United States

Palmetto Primary Care & Specialty Physicians

Summerville, South Carolina, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

K2 Medical Research Nashville

Nashville, Tennessee, United States

Senior Adults Specialty Research

Austin, Texas, United States

NeuroMind Clinical Trials

Houston, Texas, United States

Central Texas Neurology Associates

Round Rock, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

Memory Clinic, Inc.

Bennington, Vermont, United States

Sana Research

Arlington, Virginia, United States

Re:Cognition Fairfax

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06709014

Related Trials

Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease

NCT074960212 locations