Actively Recruiting
A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
Led by Annovis Bio Inc. · Updated on 2026-05-13
760
Participants Needed
81
Research Sites
173 weeks
Total Duration
On this page
Sponsors
A
Annovis Bio Inc.
Lead Sponsor
P
Prevail Infoworks
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Alzheimer's disease according to 2024 National Institute on Aging and Alzheimer's Association criteria
- Male or female aged 55 to 85 years
- Mini-Mental State Examination (MMSE) score between 20 and 28 at screening and baseline
- Clinical Dementia Rating (CDR) global score of 0.5 or 1 with memory box score at least 0.5
- Positive amyloid beta status defined by plasma p-tau217 level at screening
- MRI consistent with Alzheimer's disease diagnosis without significant abnormalities
- Have a study partner in frequent contact who will provide consent and accompany to visits
- Female participants of childbearing potential must have negative pregnancy test and agree to use effective contraception during and one month after the trial
- Male participants must be sterile, sexually inactive, or agree to use barrier contraception and ensure female partners use effective contraception
- Cognition and function sufficient to provide informed consent or with a legally authorized representative
- No current suicidal ideation or recent suicide attempt
- Stable permitted medications for at least 4 weeks prior to screening
- Adequate vision and hearing to complete assessments
- Participants previously exposed to buntanetap allowed after 28-day washout period
You will not qualify if you...
- History of unstable psychiatric disorders such as schizophrenia or bipolar disorder
- Non-Alzheimer's dementia diagnoses
- History of seizure disorder unless stable on medication
- Brain MRI showing significant abnormalities like large infarcts or tumors
- History or current long QT syndrome or abnormal ECG heart rhythms
- Uncontrolled diabetes or significant kidney or liver impairment
- Clinically significant abnormal lab values
- Imminent risk of self-harm or harm to others
- Recent cancer or malignant tumor within past year except stable cases
- Moderate to severe alcohol or substance use disorder within past 5 years
- Recent participation in another investigational drug trial within 4 weeks
- Learning disability or developmental delay
- Known allergy to the investigational drug or its components
- Currently pregnant, breastfeeding, or lactating
- Use of strong or moderate CYP3A4 inhibitors or inducers
- Uncontrolled high or low blood pressure deemed medically significant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 81 locations
1
MD First Research
Chandler, Arizona, United States, 85286
Actively Recruiting
2
Xenoscience
Phoenix, Arizona, United States, 85004
Actively Recruiting
3
Clinical Endpoints
Scottsdale, Arizona, United States, 85258
Actively Recruiting
4
Advanced Research Center
Anaheim, California, United States, 92805
Actively Recruiting
5
Hope Clinical Research
Canoga Park, California, United States, 91303
Actively Recruiting
6
Sun Valley Research
Imperial, California, United States, 92251
Actively Recruiting
7
Mary S. Easton Center for Alzheimer's Research and Care, UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
8
UC Davis Alzheimer's Disease Research Center
Sacramento, California, United States, 95816
Actively Recruiting
9
The Neuron Clinic
San Marcos, California, United States, 92069
Actively Recruiting
10
Mountain Neurological Center
Basalt, Colorado, United States, 81621
Actively Recruiting
11
CenExel Rocky Mountain
Englewood, Colorado, United States, 80113
Actively Recruiting
12
Research Center for Clinical Trials
Norwalk, Connecticut, United States, 06851
Actively Recruiting
13
Visionary Investigators Network
Aventura, Florida, United States, 33180
Actively Recruiting
14
SFM Clinical Research
Boca Raton, Florida, United States, 33487
Actively Recruiting
15
K2 Medical Research
Clermont, Florida, United States, 34711
Actively Recruiting
16
K2 Medical Research Daytona
Daytona Beach, Florida, United States, 32114
Actively Recruiting
17
Neuropsychiatric Research Center
Fort Myers, Florida, United States, 33912
Actively Recruiting
18
Velocity Clinical
Hallandale, Florida, United States, 33009
Actively Recruiting
19
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Active, Not Recruiting
20
K2 Medical Research
Lady Lake, Florida, United States, 32159
Actively Recruiting
21
Headlands Research JEM
Lake Worth, Florida, United States, 33462
Actively Recruiting
22
Accel Research Sites Lakeland (Alcanza)
Lakeland, Florida, United States, 33803
Actively Recruiting
23
K2 Medical Research
Maitland, Florida, United States, 32751
Actively Recruiting
24
ClinCloud Clinical Research
Melbourne, Florida, United States, 32940
Actively Recruiting
25
Flourish Research/Merritt Island Medical Research
Merritt Island, Florida, United States, 32952
Actively Recruiting
26
Miami Jewish Health
Miami, Florida, United States, 33137
Actively Recruiting
27
Aqualane Clinical Research
Naples, Florida, United States, 34102
Actively Recruiting
28
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
Actively Recruiting
29
Conquest Research
Orlando, Florida, United States, 32832
Actively Recruiting
30
Axiom Brain Health, LLC
Tampa, Florida, United States, 33609
Actively Recruiting
31
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
32
Accel Neurosciences
Decatur, Georgia, United States, 30030
Actively Recruiting
33
CARE (Center for Advanced Research & Education)
Gainesville, Georgia, United States, 30501
Actively Recruiting
34
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96817
Actively Recruiting
35
Re:Cognition Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
36
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
37
Charter Research Chicago
Chicago, Illinois, United States, 60618
Actively Recruiting
38
Great Lakes Clinical Trials/Flourish Research
Chicago, Illinois, United States, 60640
Actively Recruiting
39
Southern Illinois University
Springfield, Illinois, United States, 62702
Actively Recruiting
40
JWM Research
Indianaopolis, Indiana, United States, 46256
Actively Recruiting
41
Ascension via Christi Research
Wichita, Kansas, United States, 37214
Actively Recruiting
42
Tandem Intermediate
Metairie, Louisiana, United States, 70006
Actively Recruiting
43
Headlands Research Pharmasite
Pikesville, Maryland, United States, 21208
Actively Recruiting
44
Neurology Center of New England, PC
Foxborough, Massachusetts, United States, 02035
Actively Recruiting
45
Headlands Research Easter Massachusetts
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
46
Mayflower Clinical
Russells Mills, Massachusetts, United States, 02747
Actively Recruiting
47
Elixia MA
Springfield, Massachusetts, United States, 01103
Actively Recruiting
48
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
49
Precise Research Center
Flowood, Mississippi, United States, 39232
Actively Recruiting
50
Clinical Research Professionals - Headlands Research
Chesterfield, Missouri, United States, 63005
Actively Recruiting
51
Oasis Clinical Trials LLC
Las Vegas, Nevada, United States, 89121
Actively Recruiting
52
Cenexel Advanced Medical Research of New Jersey (AMRI)
Toms River, New Jersey, United States, 08755
Actively Recruiting
53
Advanced Clinical Institute
West Long Branch, New Jersey, United States, 07764
Actively Recruiting
54
Dent Neurologic Institute
Amherst, New York, United States, 14226
Actively Recruiting
55
SPRI
Brooklyn, New York, United States, 11235
Actively Recruiting
56
Neurological Associates of Long Island
Lake Success, New York, United States, 11042
Actively Recruiting
57
Parker Jewish Institute for Health Care and Rehab
New Hyde Park, New York, United States, 11040
Active, Not Recruiting
58
New York Neurology Associates
New York, New York, United States, 10003
Active, Not Recruiting
59
Richmond Behavioral Associates
Staten Island, New York, United States, 10314
Actively Recruiting
60
Ichor Research
Syracuse, New York, United States, 13210
Actively Recruiting
61
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
62
AMC Research/Flourish Research
Matthews, North Carolina, United States, 28105
Actively Recruiting
63
Eximia Clinical Research
Raleigh, North Carolina, United States, 27607
Active, Not Recruiting
64
American Clinical Research Center
Beavercreek, Ohio, United States, 45432
Actively Recruiting
65
Valley Medical Research
Centerville, Ohio, United States, 45459
Actively Recruiting
66
Insight Clinical Trials
Independence, Ohio, United States, 44131
Actively Recruiting
67
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
68
Summit Headlands
Portland, Oregon, United States, 97210
Actively Recruiting
69
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Actively Recruiting
70
K2 Keystone
Plymouth Meeting, Pennsylvania, United States, 19462
Actively Recruiting
71
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States, 02914
Actively Recruiting
72
Palmetto Primary Care & Specialty Physicians
Summerville, South Carolina, United States, 29486
Actively Recruiting
73
Neurology Clinic, P.C.
Cordova, Tennessee, United States, 38018
Actively Recruiting
74
K2 Medical Research Nashville
Nashville, Tennessee, United States, 37204
Actively Recruiting
75
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Actively Recruiting
76
NeuroMind Clinical Trials
Houston, Texas, United States, 77094
Actively Recruiting
77
Central Texas Neurology Associates
Round Rock, Texas, United States, 78681
Actively Recruiting
78
Grayline Research Center
Wichita Falls, Texas, United States, 76309
Actively Recruiting
79
Memory Clinic, Inc.
Bennington, Vermont, United States, 05201
Actively Recruiting
80
Sana Research
Arlington, Virginia, United States, 22205
Actively Recruiting
81
Re:Cognition Fairfax
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sarah MacCallum, BA, BSN
CONTACT
A
Alexander Morin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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