Clinical Trial on Agitation in Alzheimer's Dementia

Part of paid clinical trials in Maitland, Florida.

Sponsor
IGC Pharma, LLC
Study ID
NCT05543681
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IGC-AD1-Active — DRUG
    A non-sterile solution for oral administration.
  • IGC-AD1-Placebo — DRUG
    A non-sterile solution for oral administration similar in color and texture to the Active.

Study Details

The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.

Key Dates

Start date
Oct 11, 2022
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Comparator: IGC-AD1Active
    IGC-AD1-Active, oral solution with two APIs (THC and melatonin).
  • Placebo Comparator: Placebo Comparator: IGC-AD1 Placebo
    IGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs.

Primary Outcome Measure

Agitation [ Time Frame: Baseline to week six ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
ClinCloud, LLCMaitlandFlorida32751-
ClinCloud, LLCMelbourneFlorida32940-
Central Miami Medical InstituteMiamiFlorida33125-
Miami Jewish HealthMiamiFlorida33137-
Visionary Investigators NetworkMiamiFlorida33133-
Neurostudies Inc.Port CharlotteFlorida33952-
BayCare Health System Inc.St. PetersburgFlorida33705-
University of South Florida Department of Psychiatry and Behavioral NeurosciencesTampaFlorida33613-
Tandem Clinical Research GI, LLCMetairieLouisiana70006-
MedStar Franklin Square Medical Center NeurologyBaltimoreMaryland21237-
Medstar Southern Maryland Hospital CenterClintonMaryland20735-
Medstar Montgomery Medical CenterOlneyMaryland20832-
Tekton Research LLCSt LouisMissouri63128-
Dent Neurologic InstituteAmherstNew York02459-
Integrative Clinical Trials, LLCBrooklynNew York11229-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Ichor ResearchSyracuseNew York13210-
Lynn Health Science Institute (LHSI)Oklahoma CityOklahoma73112-
Butler Hospital, Brown UniversityProvidenceRhode Island02906-
Senior Adults Specialty ResearchAustinTexas78757-
Baylor Scott and White Research InstituteDallasTexas75231-
Kerwin Medical CenterDallasTexas75231-
Dominion Medical Associates, Inc.RichmondVirginia23219-

Find similar trials in Maitland, FL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
ClinCloud, LLC· Maitland, FLClinCloud, LLC· Melbourne, FLCentral Miami Medical Institute· Miami, FLMiami Jewish Health· Miami, FLVisionary Investigators Network· Miami, FLNeurostudies Inc.· Port Charlotte, FL

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