| Condition or Disease | Intervention/Treatment |
|---|---|
Early Alzheimers Disease | Drug: buntanetap/posiphenDrug: Placebo |
ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .
| Condition or Disease | Intervention/Treatment |
|---|---|
Early Alzheimers Disease | Drug: buntanetap/posiphenDrug: Placebo |
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 760 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | February 3, 2025 |
| Actual Primary Completion Date | 1yr 6mos from now |
| Actual Study Completion Date | 2yrs 2w from now |
| Group/Cohort | Intervention/Treatment |
|---|---|
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| Ages Eligible for Study | (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria | 1. Diagnosis of AD according to the 2024 National Institute on Aging and Alzheimer's Association criteria. 2. Male or female, aged 55 - 85 years. 3. MMSE 20-28 at screening and baseline. 4. CDR global score=0.5 or 1, with memory box score at least 0.5 at screening and baseline. 5. Positive for amyloid beta as defined by plasma p-tau217 level at screening. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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. 11. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale. 12. 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. 13. Adequate visual and hearing ability (physical ability to perform all the study assessments). 14. Participants previously exposed to buntanetap can still be included in the study after a 28-day wash out period. |
| Exclusion Criteria | 1. 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. 2. Has non-AD dementia, such as vascular dementia, Lewy body dementia, frontotemporal disease, PD dementia, B12 and thyroid deficiency caused dementia. 3. History of a seizure disorder, if stable on medication is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications. 4. 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). 5. 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. 6. Has bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG at screening and deemed medically significant by the PI. 7. 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. 8. 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). 9. 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. 10. 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. 11. 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). 12. Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM. 13. 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. 14. Participants with learning disability or developmental delay. 15. Participants whom the PI deems to be otherwise ineligible. 16. 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) 17. Participant is currently pregnant, breast-feeding, and/or lactating. 18. 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. 19. 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. |
| Sponsors and Collaborators | Annovis Bio Inc. |
|---|---|
| Locations | MD First Research | Chandler Arizona, United States, 85286Xenoscience | Phoenix Arizona, United States, 85004Clinical Endpoints | Scottsdale Arizona, United States, 85258Advanced Research Center | Anaheim California, United States, 92805Hope Clinical Research | Canoga Park California, United States, 91303Sun Valley Research | Imperial California, United States, 92251Mary S. Easton Center for Alzheimer's Research and Care, UCLA | Los Angeles California, United States, 90095UC Davis Alzheimer's Disease Research Center | Sacramento California, United States, 95816The Neuron Clinic | San Marcos California, United States, 92069Mountain Neurological Center | Basalt Colorado, United States, 81621CenExel Rocky Mountain | Englewood Colorado, United States, 80113Research Center for Clinical Trials | Norwalk Connecticut, United States, 06851Visionary Investigators Network | Aventura Florida, United States, 33180SFM Clinical Research | Boca Raton Florida, United States, 33487K2 Medical Research | Clermont Florida, United States, 34711K2 Medical Research Daytona | Daytona Beach Florida, United States, 32114Neuropsychiatric Research Center | Fort Myers Florida, United States, 33912Velocity Clinical | Hallandale Florida, United States, 33009Jacksonville Center for Clinical Research | Jacksonville Florida, United States, 32216K2 Medical Research | Lady Lake Florida, United States, 32159Headlands Research JEM | Lake Worth Florida, United States, 33462Accel Research Sites Lakeland (Alcanza) | Lakeland Florida, United States, 33803K2 Medical Research | Maitland Florida, United States, 32751ClinCloud Clinical Research | Melbourne Florida, United States, 32940Flourish Research/Merritt Island Medical Research | Merritt Island Florida, United States, 32952Miami Jewish Health | Miami Florida, United States, 33137Aqualane Clinical Research | Naples Florida, United States, 34102Suncoast Clinical Research | New Port Richey Florida, United States, 34652Conquest Research | Orlando Florida, United States, 32832Axiom Brain Health, LLC | Tampa Florida, United States, 33609Conquest Research | Winter Park Florida, United States, 32789Accel Neurosciences | Decatur Georgia, United States, 30030CARE (Center for Advanced Research & Education) | Gainesville Georgia, United States, 30501Hawaii Pacific Neuroscience | Honolulu Hawaii, United States, 96817Re:Cognition Chicago | Chicago Illinois, United States, 60611Rush University Medical Center | Chicago Illinois, United States, 60612Charter Research Chicago | Chicago Illinois, United States, 60618Great Lakes Clinical Trials/Flourish Research | Chicago Illinois, United States, 60640Southern Illinois University | Springfield Illinois, United States, 62702JWM Research | Indianaopolis Indiana, United States, 46256Ascension via Christi Research | Wichita Kansas, United States, 37214Tandem Intermediate | Metairie Louisiana, United States, 70006Headlands Research Pharmasite | Pikesville Maryland, United States, 21208Neurology Center of New England, PC | Foxborough Massachusetts, United States, 02035Headlands Research Easter Massachusetts | Plymouth Massachusetts, United States, 02360Mayflower Clinical | Russells Mills Massachusetts, United States, 02747Elixia MA | Springfield Massachusetts, United States, 01103Quest Research Institute | Farmington Hills Michigan, United States, 48334Precise Research Center | Flowood Mississippi, United States, 39232Clinical Research Professionals - Headlands Research | Chesterfield Missouri, United States, 63005Oasis Clinical Trials LLC | Las Vegas Nevada, United States, 89121Cenexel Advanced Medical Research of New Jersey (AMRI) | Toms River New Jersey, United States, 08755Advanced Clinical Institute | West Long Branch New Jersey, United States, 07764Dent Neurologic Institute | Amherst New York, United States, 14226SPRI | Brooklyn New York, United States, 11235Neurological Associates of Long Island | Lake Success New York, United States, 11042Parker Jewish Institute for Health Care and Rehab | New Hyde Park New York, United States, 11040New York Neurology Associates | New York New York, United States, 10003Richmond Behavioral Associates | Staten Island New York, United States, 10314Ichor Research | Syracuse New York, United States, 13210Duke University | Durham North Carolina, United States, 27705AMC Research/Flourish Research | Matthews North Carolina, United States, 28105Eximia Clinical Research | Raleigh North Carolina, United States, 27607American Clinical Research Center | Beavercreek Ohio, United States, 45432Valley Medical Research | Centerville Ohio, United States, 45459Insight Clinical Trials | Independence Ohio, United States, 44131Lynn Health Science Institute | Oklahoma City Oklahoma, United States, 73112Summit Headlands | Portland Oregon, United States, 97210Suburban Research Associates | Media Pennsylvania, United States, 19063K2 Keystone | Plymouth Meeting Pennsylvania, United States, 19462Rhode Island Mood and Memory Research Institute | East Providence Rhode Island, United States, 02914Palmetto Primary Care & Specialty Physicians | Summerville South Carolina, United States, 29486Neurology Clinic, P.C. | Cordova Tennessee, United States, 38018K2 Medical Research Nashville | Nashville Tennessee, United States, 37204Senior Adults Specialty Research | Austin Texas, United States, 78757NeuroMind Clinical Trials | Houston Texas, United States, 77094Central Texas Neurology Associates | Round Rock Texas, United States, 78681Grayline Research Center | Wichita Falls Texas, United States, 76309Memory Clinic, Inc. | Bennington Vermont, United States, 05201Sana Research | Arlington Virginia, United States, 22205Re:Cognition Fairfax | Fairfax Virginia, United States, 22031 |
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