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

Status: Recruiting
Location: See all (85) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• Diagnosis of AD according to the 2024 National Institute on Aging and Alzheimer's Association criteria.

• Male or female, aged 55 - 85 years.

• MMSE 21-28 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.

• 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.

• 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,

⁃ Bilateral tubal occlusion.

⁃ 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.

⁃ No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale.

⁃ 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.

⁃ Adequate visual and hearing ability (physical ability to perform all the study assessments).

⁃ Participants previously exposed to buntanetap can still be included in the study after a 28-day wash out period.

Locations
United States
Arizona
MD First Research
RECRUITING
Chandler
Xenoscience
NOT_YET_RECRUITING
Phoenix
Clinical Endpoints
RECRUITING
Scottsdale
California
Advanced Research Center
RECRUITING
Anaheim
Hope Clinical Research
RECRUITING
Canoga Park
Eximia Clinical Research
RECRUITING
Encino
Sun Valley Research
RECRUITING
Imperial
Mary S. Easton Center for Alzheimer's Research and Care, UCLA
NOT_YET_RECRUITING
Los Angeles
UC Davis Alzheimer's Disease Research Center
RECRUITING
Sacramento
The Neuron Clinic
RECRUITING
San Marcos
Colorado
Mountain Neurological Center
RECRUITING
Basalt
CenExel Rocky Mountain
RECRUITING
Englewood
Connecticut
Research Center for Clinical Trials
RECRUITING
Norwalk
Florida
Visionary Investigators Network
RECRUITING
Aventura
SFM Clinical Research
RECRUITING
Boca Raton
K2 Medical Research
RECRUITING
Clermont
K2 Medical Research Daytona
RECRUITING
Daytona Beach
Neuropsychiatric Research Center
RECRUITING
Fort Myers
Velocity Clinical
RECRUITING
Hallandale
Jacksonville Center for Clinical Research
RECRUITING
Jacksonville
K2 Medical Research
RECRUITING
Lady Lake
Headlands Research JEM
RECRUITING
Lake Worth
Accel Research Sites Lakeland (Alcanza)
RECRUITING
Lakeland
K2 Medical Research
RECRUITING
Maitland
ClinCloud Clinical Research
RECRUITING
Melbourne
Flourish Research/Merritt Island Medical Research
RECRUITING
Merritt Island
Miami Jewish Health
RECRUITING
Miami
Aqualane Clinical Research
RECRUITING
Naples
Suncoast Clinical Research
RECRUITING
New Port Richey
Conquest Research
RECRUITING
Orlando
Axiom Brain Health, LLC
NOT_YET_RECRUITING
Tampa
Conquest Research
RECRUITING
Winter Park
Georgia
Accel Neurosciences
RECRUITING
Decatur
CARE (Center for Advanced Research & Education)
RECRUITING
Gainesville
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Illinois
Charter Research Chicago
RECRUITING
Chicago
Great Lakes Clinical Trials/Flourish Research
RECRUITING
Chicago
Re:Cognition Chicago
RECRUITING
Chicago
Rush University Medical Center
NOT_YET_RECRUITING
Chicago
Southern Illinois University
RECRUITING
Springfield
Indiana
JWM Research
RECRUITING
Indianaopolis
Kansas
Ascension via Christi Research
RECRUITING
Wichita
Louisiana
Care Access
RECRUITING
Lake Charles
Tandem Intermediate
RECRUITING
Metairie
Massachusetts
Neurology Center of New England, PC
NOT_YET_RECRUITING
Foxborough
Headlands Research Easter Massachusetts
RECRUITING
Plymouth
Mayflower Clinical
NOT_YET_RECRUITING
Russells Mills
Elixia MA
RECRUITING
Springfield
Maryland
Headlands Research Pharmasite
RECRUITING
Pikesville
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
Missouri
Headlands Research CRP
RECRUITING
Chesterfield
Mississippi
Precise Research Center
RECRUITING
Flowood
North Carolina
Duke University
RECRUITING
Durham
AMC Research/Flourish Research
RECRUITING
Matthews
Eximia Clinical Research
RECRUITING
Raleigh
New Jersey
Cenexel Advanced Medical Research of New Jersey (AMRI)
RECRUITING
Toms River
Advanced Clinical Institute
RECRUITING
West Long Branch
Nevada
Oasis Clinical Trials LLC
NOT_YET_RECRUITING
Las Vegas
New York
Dent Neurologic Institute
NOT_YET_RECRUITING
Amherst
SPRI
NOT_YET_RECRUITING
Brooklyn
Neurological Associates of Long Island
NOT_YET_RECRUITING
Lake Success
Parker Jewish Institute for Health Care and Rehab
RECRUITING
New Hyde Park
New York Neurology Associates
RECRUITING
New York
Richmond Behavioral Associates
RECRUITING
Staten Island
Ichor Research
RECRUITING
Syracuse
Ohio
American Clinical Research Center
RECRUITING
Beavercreek
Valley Medical Research
RECRUITING
Centerville
Insight Clinical Trials
RECRUITING
Independence
Oklahoma
Lynn Health Science Institute
RECRUITING
Oklahoma City
Oregon
Summit Headlands
RECRUITING
Portland
Pennsylvania
Abington Neurologic Associates
NOT_YET_RECRUITING
Abington
Suburban Research Associates
RECRUITING
Media
K2 Keystone
NOT_YET_RECRUITING
Plymouth Meeting
Rhode Island
Rhode Island Mood and Memory Research Institute
RECRUITING
East Providence
South Carolina
Palmetto Primary Care & Specialty Physicians
NOT_YET_RECRUITING
Summerville
Tennessee
Neurology Clinic, P.C.
RECRUITING
Cordova
K2 Medical Research Nashville
RECRUITING
Nashville
Texas
Senior Adults Specialty Research
RECRUITING
Austin
ANESC
NOT_YET_RECRUITING
El Paso
NeuroMind Clinical Trials
RECRUITING
Houston
Central Texas Neurology Associates
RECRUITING
Round Rock
Grayline Research Center
RECRUITING
Wichita Falls
Virginia
Sana Research
RECRUITING
Arlington
Re:Cognition Fairfax
RECRUITING
Fairfax
Vermont
Memory Clinic, Inc.
RECRUITING
Bennington
Contact Information
Primary
Sarah MacCallum, BA, BSN
maccallum@annovisbio.com
484-875-3192
Backup
Melissa Gaines
gaines@annovisbio.com
484-875-3192
Time Frame
Start Date: 2025-02-04
Estimated Completion Date: 2028-06
Participants
Target number of participants: 760
Treatments
Experimental: buntanetap
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Annovis Bio Inc.
Collaborators: Prevail Infoworks

This content was sourced from clinicaltrials.gov