Actively Recruiting
A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of IGC-AD1 on Agitation in Alzheimer's Dementia
Led by IGC Pharma, LLC · Updated on 2026-05-20
164
Participants Needed
31
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of IGC-AD1, an oral medication containing THC and melatonin, on agitation in patients aged 60 and older with mild to severe Alzheimer's dementia. The study is a multi-center, double-blind, randomized, placebo-controlled clinical trial aiming to assess how IGC-AD1 impacts agitation symptoms compared to a placebo. Participants must have clinically significant agitation lasting at least two weeks and meet specific criteria to ensure the agitation is related to Alzheimer's dementia. Participants will receive either the active oral solution of IGC-AD1 or a placebo, both administered twice daily for 42 days followed by a two-day dose taper. The study includes safety monitoring with frequent phone calls to review medication use, adverse events, and study partner logbook entries. Blood samples will be taken during the trial to analyze drug levels, brain-related biomarkers, and genetic factors. During the study, participants and their caregivers will complete various assessments, including the Cohen-Mansfield Agitation Inventory (CMAI) to measure changes in agitation over six weeks and at two weeks. Safety and medication adherence will be closely monitored. The total participation time includes the treatment period and follow-up safety calls. Researchers will also evaluate secondary and exploratory outcomes related to agitation and collect pharmacokinetic data.
CONDITIONS
Brief Title
Clinical Trial on Agitation in Alzheimer's Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant and/or caregiver must provide signed consent before any study procedures.
- Must have a caregiver able and willing to comply with all study procedures.
- Caregiver must be known to the participant and able to use electronic devices and learn basic health measurements.
- Participants unable to consent may have caregiver consent if allowed by local practice and relationship.
- Participants must consent to genotyping and pharmacokinetic testing.
- Diagnosis of Alzheimer's disease by NIA-AA criteria.
- Clinically significant agitation with NPI agitation score 64 and persistent agitation per IPA criteria, not due to other causes.
- Negative drug screen except stable benzodiazepine use allowed.
- Behavioral medications stable for at least 6 weeks with limited dose changes.
- Women must be postmenopausal for at least 12 months or surgically sterile.
You will not qualify if you...
- Prior adverse reaction to cannabinoids or any study drug component.
- Serious or unstable medical illnesses that affect safety assessments.
- History of seizures, schizophrenia, or bipolar disorder.
- Participation in investigational drug or device study within 30 days before starting.
- Positive urine drug screen except stable benzodiazepine use.
- History of alcohol or drug use disorder within one year.
- Uncontrolled hypertension or hypertensive crisis within 6 months.
- History of recurrent falls or falls causing injury related to acute illness or abnormal blood pressure.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 42 days of treatment plus a 2-day taper period
Participants receive the investigational oral solution containing THC and melatonin or placebo for agitation in Alzheimer's dementia.
Daily calls on days 2, 3, and 4, then calls every third day thereafter
Trial Site Locations
Total: 31 locations
1
ClinCloud, LLC
Maitland, Florida, United States, 32751
Active, Not Recruiting
2
ClinCloud, LLC
Melbourne, Florida, United States, 32940
Actively Recruiting
3
Central Miami Medical Institute
Miami, Florida, United States, 33125
Actively Recruiting
4
Visionary Investigators Network
Miami, Florida, United States, 33133
Actively Recruiting
5
Miami Jewish Health
Miami, Florida, United States, 33137
Actively Recruiting
6
Neurostudies Inc.
Port Charlotte, Florida, United States, 33952
Actively Recruiting
7
BayCare Health System Inc.
St. Petersburg, Florida, United States, 33705
Actively Recruiting
8
University of South Florida Department of Psychiatry and Behavioral Neurosciences
Tampa, Florida, United States, 33613
Actively Recruiting
9
Tandem Clinical Research GI, LLC
Metairie, Louisiana, United States, 70006
Actively Recruiting
10
MedStar Franklin Square Medical Center Neurology
Baltimore, Maryland, United States, 21237
Actively Recruiting
11
Medstar Southern Maryland Hospital Center
Clinton, Maryland, United States, 20735
Actively Recruiting
12
Medstar Montgomery Medical Center
Olney, Maryland, United States, 20832
Actively Recruiting
13
Tekton Research LLC
St Louis, Missouri, United States, 63128
Actively Recruiting
14
Dent Neurologic Institute
Amherst, New York, United States, 02459
Actively Recruiting
15
Integrative Clinical Trials, LLC
Brooklyn, New York, United States, 11229
Actively Recruiting
16
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
17
Ichor Research
Syracuse, New York, United States, 13210
Actively Recruiting
18
Lynn Health Science Institute (LHSI)
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
19
Butler Hospital, Brown University
Providence, Rhode Island, United States, 02906
Actively Recruiting
20
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Actively Recruiting
21
Baylor Scott and White Research Institute
Dallas, Texas, United States, 75231
Actively Recruiting
22
Kerwin Medical Center
Dallas, Texas, United States, 75231
Actively Recruiting
23
Dominion Medical Associates, Inc.
Richmond, Virginia, United States, 23219
Actively Recruiting
24
Island Health Authorities
Victoria, British Columbia, Canada, V8R 1J8
Actively Recruiting
25
Hamilton Health Sciences , Mcmaster University
Hamilton, Ontario, Canada, L8M 1W9
Actively Recruiting
26
Baycrest Academy for Research and Education , University of Toronto
Toronto, Ontario, Canada, ON M6A 2E1
Actively Recruiting
27
Douglas Hospital Research Center, McGill university
Montreal, Quebec, Canada, H4H 1R3
Actively Recruiting
28
Grupo de Neurociencias de Antioquia, Universidad de Antioquia
Medellín, Antioquia, Colombia
Active, Not Recruiting
29
Instituto Sanacoop
Bayamón, Bayamón, Puerto Rico, 00961
Completed
30
SCB Research Center Corp
Bayamón, Puerto Rico, 00961
Actively Recruiting
31
The Alliance, Medical Sciences Campus University of Puerto Rico
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
Research Team
E
Evelyn Gutiérrez
M
Margarita Venegas
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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