A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Annovis Bio Inc.
Study ID
NCT05686044
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Buntanetap/Posiphen — DRUG
    HPMC (vegetarian source) capsule shells
  • Placebo — DRUG
    HPMC (vegetarian source) capsule shells

Study Details

The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild to moderate Alzheimer's disease. Study details include: The double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home. The study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.

Key Dates

Start date
Apr 1, 2023
Status verified
Apr 2025
Primary completion
Feb 13, 2024
Completion
Feb 13, 2024

Study Design

Enrollment
351 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 7.5mg Buntanetap/Posiphen
    Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
  • Experimental: 15mg Buntanetap/Posiphen
    Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
  • Experimental: 30mg Buntanetap/Posiphen
    Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
  • Placebo Comparator: Placebo
    Placebo oral capsule with daily administration for a period of 12 weeks

Primary Outcome Measure

Change From Baseline to Week 12 in ADAS-Cog11 [ Time Frame: Baseline to the end of treatment period (12 weeks) ]

Locations (54)

FacilityCityStateZIPSite coordinators
CCT Research - Gilbert Neurology PartnersGilbertArizona85297-
CCT Research - Foothills CenterPhoenixArizona85004-
The Belinga ClinicFort SmithArkansas72916-
Sun Valley Research CenterImperialCalifornia92251-
CenExel Clinical Clinical Research, IncLos AlamitosCalifornia90720-
Cenexel Rocky Mountain Clinical ResearchEnglewoodColorado80113-
Ki Health Partners LLC D/B/A New England Institute for Clinical ResearchStamfordConnecticut06824-
Visionary Investigators NetworkAventuraFlorida33180-
K2 Medical ResearchClermontFlorida34711-
The Neurology Institute - Coral SpringsCoral SpringsFlorida33067-4640-
JY Research Inst.Cutler BayFlorida33189-
Arrow Clinical trialDaytona BeachFlorida32114-
Accel Research Sites - DeLand Clinical Research UnitDeLandFlorida32720-
New Life Medical Research CenterHialeahFlorida33012-
CenExel RCAHollywoodFlorida33024-
Coral Clinic Reserach LLCHomesteadFlorida33032-
Charter ResearchLady LakeFlorida32159-
ClinCloud, LLCMaitlandFlorida32751-
K2 Medical ResearchMaitlandFlorida32751-
Merritt Island Clinical Research LLCMerritt IslandFlorida32952-
Ezy Medical Research Co.MiamiFlorida33175-
Gold Coast Health Research, LLCMiamiFlorida33155-
Medical Professional Clinical Research Center, IncMiamiFlorida33165-
Nuovida Research CenterMiamiFlorida33186-
Premier Clinical Research Institute, IncMiamiFlorida33122-
Reliant Medical ResearchMiamiFlorida33165-
Renstar Medical ResearchOcalaFlorida34470-
Visionary Investigators NetworkPembroke PinesFlorida33026-
Napa ResearchPompano BeachFlorida33064-
K2 Medical ResearchTampaFlorida33067-
K2 Summit ResearchThe VillagesFlorida32159-
ClinCloud, LLCVieraFlorida32940-
Charter ResearchWinter ParkFlorida32792-
Conquest Research, LLCWinter ParkFlorida32789-
CenExel iResearch, LLCDecaturGeorgia30030-
Center for Advanced Research & EducationGainesvilleGeorgia30501-
Hawaii Pacific Neuroscience, LLCHonoluluHawaii96817-
Southern Illinois University School of MedicineSpringfieldIllinois62702-
Josephson Wallack Munshower Neurology, P.C.IndianapolisIndiana46256-
Northern Light Acadia HospitalBangorMaine04401-
MedVadis ResearchWalthamMassachusetts02451-
Quest Research InstitueFarmington HillsMichigan48334-
Insight Research InstituteFlintMichigan48507-
Hassman Research InstituteBerlinNew Jersey08009-
CenExel Clinical Research, IncToms RiverNew Jersey08755-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Velocity Clinical ResearchSyracuseNew York13057-
Duke UniversityDurhamNorth Carolina27705-
Neuroscience Centre (CINAC)CantonOhio44718-
Dayton Center for Neurological Disorders, IncCentervilleOhio45459-
NeuroCare PlusHoustonTexas77094-
Be Well Clinical Studies, LLCRound RockTexas78681-
Central Texas Neurology ConsultantsRound RockTexas78681-
Inland Northwest ResearchSpokaneWashington99202-1342-

Related coverage on Hipa.ai

Find similar trials in Gilbert, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
CCT Research - Gilbert Neurology Partners· Gilbert, AZCCT Research - Foothills Center· Phoenix, AZThe Belinga Clinic· Fort Smith, ARSun Valley Research Center· Imperial, CACenExel Clinical Clinical Research, Inc· Los Alamitos, CACenexel Rocky Mountain Clinical Research· Englewood, CO

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