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Early Alzheimers DiseasePhase 3NCT06709014

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

A Phase 3 study testing buntanetap/posiphen in people with Early Alzheimers Disease, run by Annovis Bio Inc. at 78 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Early Alzheimers Disease
What is being tested?
buntanetap/posiphen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
760 participants
Where
78 sitesUnited States
Study dates
4 Feb 2025to Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
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  • 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.

Who cannot join

  • 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.
  • Has non-AD dementia, such as vascular dementia, Lewy body dementia, frontotemporal disease, PD dementia, B12 and thyroid deficiency caused dementia.
  • History of a seizure disorder, if stable on medication is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications.
  • 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).
  • 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.
  • Has bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening and deemed medically significant by the PI.
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  • 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.
  • 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).
  • 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.
  • 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.
  • 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).
  • Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM.
  • 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.
  • Participants with learning disability or developmental delay.
  • Participants whom the PI deems to be otherwise ineligible.
  • 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)
  • Participant is currently pregnant, breast-feeding, and/or lactating.
  • 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.
  • 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.

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

United States78 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Advanced Research Center

    Anaheim, California, 92805

  • Sana Research

    Arlington, Virginia, 22205

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • Visionary Investigators Network

    Aventura, Florida, 33180

  • Mountain Neurological Center

    Basalt, Colorado, 81621

  • American Clinical Research Center

    Beavercreek, Ohio, 45432

  • Memory Clinic, Inc.

    Bennington, Vermont, 05201

  • SFM Clinical Research

    Boca Raton, Florida, 33487

  • SPRI

    Brooklyn, New York, 11235

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Valley Medical Research

    Centerville, Ohio, 45459

  • MD First Research

    Chandler, Arizona, 85286

  • Clinical Research Professionals - Headlands Research

    Chesterfield, Missouri, 63005

  • Re:Cognition Chicago

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Charter Research Chicago

    Chicago, Illinois, 60618

  • Great Lakes Clinical Trials/Flourish Research

    Chicago, Illinois, 60640

  • K2 Medical Research

    Clermont, Florida, 34711

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • K2 Medical Research Daytona

    Daytona Beach, Florida, 32114

  • Accel Neurosciences

    Decatur, Georgia, 30030

  • Duke University

    Durham, North Carolina, 27705

  • Rhode Island Mood and Memory Research Institute

    East Providence, Rhode Island, 02914

  • CenExel Rocky Mountain

    Englewood, Colorado, 80113

  • Re:Cognition Fairfax

    Fairfax, Virginia, 22031

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Precise Research Center

    Flowood, Mississippi, 39232

  • Neuropsychiatric Research Center

    Fort Myers, Florida, 33912

  • Neurology Center of New England, PC

    Foxborough, Massachusetts, 02035

  • CARE (Center for Advanced Research & Education)

    Gainesville, Georgia, 30501

  • Velocity Clinical

    Hallandale, Florida, 33009

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • NeuroMind Clinical Trials

    Houston, Texas, 77094

  • Sun Valley Research

    Imperial, California, 92251

  • Insight Clinical Trials

    Independence, Ohio, 44131

  • JWM Research

    Indianaopolis, Indiana, 46256

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • K2 Medical Research

    Lady Lake, Florida, 32159

  • Neurological Associates of Long Island

    Lake Success, New York, 11042

  • Headlands Research JEM

    Lake Worth, Florida, 33462

  • Accel Research Sites Lakeland (Alcanza)

    Lakeland, Florida, 33803

  • Oasis Clinical Trials LLC

    Las Vegas, Nevada, 89121

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

    Los Angeles, California, 90095

  • K2 Medical Research

    Maitland, Florida, 32751

  • AMC Research/Flourish Research

    Matthews, North Carolina, 28105

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • ClinCloud Clinical Research

    Melbourne, Florida, 32940

  • Flourish Research/Merritt Island Medical Research

    Merritt Island, Florida, 32952

  • Tandem Intermediate

    Metairie, Louisiana, 70006

  • Miami Jewish Health

    Miami, Florida, 33137

  • Aqualane Clinical Research

    Naples, Florida, 34102

  • K2 Medical Research Nashville

    Nashville, Tennessee, 37204

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • New York Neurology Associates

    New York, New York, 10003

  • Research Center for Clinical Trials

    Norwalk, Connecticut, 06851

  • Conquest Research

    Orlando, Florida, 32832

  • Xenoscience

    Phoenix, Arizona, 85004

  • Headlands Research Pharmasite

    Pikesville, Maryland, 21208

  • Headlands Research Easter Massachusetts

    Plymouth, Massachusetts, 02360

  • K2 Keystone

    Plymouth Meeting, Pennsylvania, 19462

  • Summit Headlands

    Portland, Oregon, 97210

  • Central Texas Neurology Associates

    Round Rock, Texas, 78681

  • Mayflower Clinical

    Russells Mills, Massachusetts, 02747

  • UC Davis Alzheimer's Disease Research Center

    Sacramento, California, 95816

  • The Neuron Clinic

    San Marcos, California, 92069

  • Clinical Endpoints

    Scottsdale, Arizona, 85258

  • Southern Illinois University

    Springfield, Illinois, 62702

  • Elixia MA

    Springfield, Massachusetts, 01103

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

  • Palmetto Primary Care & Specialty Physicians

    Summerville, South Carolina, 29486

  • Ichor Research

    Syracuse, New York, 13210

  • Axiom Brain Health, LLC

    Tampa, Florida, 33609

  • Cenexel Advanced Medical Research of New Jersey (AMRI)

    Toms River, New Jersey, 08755

  • Advanced Clinical Institute

    West Long Branch, New Jersey, 07764

  • Ascension via Christi Research

    Wichita, Kansas, 37214

  • Grayline Research Center

    Wichita Falls, Texas, 76309

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: 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

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?
Read more

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
Being tested
buntanetap/posiphen, Placebo
Keywords
Early Alzheimers disease, Early AD, AD, mild cognitive impairment, MCI, buntanetap, posiphen
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • buntanetap/posiphenDrug

    30mg capsule by mouth once daily for 18 months

  • PlaceboDrug

    Placebo capsule by mouth once daily for 18 months

Study groups in NCT06709014
Study groupRoleWhat they receive
buntanetapExperimentalNot described
Receives: Drug: buntanetap/posiphen
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start4 Feb 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
760 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06709014
Sponsor's protocol ID
ANVS-25001
Status last verified
May 2026
First submitted
26 Nov 2024
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing buntanetap/posiphen in people with Early Alzheimers Disease, run by Annovis Bio Inc. at 78 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) (time frame: From screening to 6-month readout, to end of treatment at 18 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06709014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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