Actively Recruiting
Clinical Trial on Agitation in Alzheimer's Dementia
Led by IGC Pharma, LLC · Updated on 2026-04-14
164
Participants Needed
30
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial on Agitation in Alzheimer's Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or caregiver must sign informed consent before any study procedures
- Participant must have a caregiver willing and able to comply with study requirements
- Caregiver must be familiar with electronic devices like cell phones and able to learn to take blood pressure
- Caregiver consent allowed if participant cannot consent, following local practices
- Participant must agree to genetic testing and pharmacokinetic studies
- Diagnosis of Alzheimer's disease by NIA-AA criteria
- Clinically significant agitation with NPI agitation score of 4 or higher
- Persistent agitation per International Psychogeriatric Association criteria
- Agitation not caused by other psychiatric or medical conditions or substances
- Negative drug screen except benzodiazepines if stable for at least 3 months
- Behavioral symptom medications stable for at least 6 weeks with minimal dose changes
- Women must be postmenopausal or surgically sterile
You will not qualify if you...
- Prior adverse reaction to cannabinoids or any component of study drug
- Serious or unstable medical illnesses affecting safety assessment
- History of seizures, schizophrenia, or bipolar disorder
- Participation in another investigational study within 30 days
- Positive urine drug screen for illicit drugs except stable benzodiazepines
- History of alcohol or drug use disorder within the past year
- Uncontrolled hypertension or hypertensive crisis in past 6 months
- History of recurrent falls or falls with injury related to acute illness or abnormal blood pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 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
Metaire, 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
Not Yet Recruiting
16
Ichor Research
Syracuse, New York, United States, 13210
Actively Recruiting
17
Lynn Health Science Institute (LHSI)
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
18
Butler Hospital, Brown University
Providence, Rhode Island, United States, 02906
Actively Recruiting
19
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Actively Recruiting
20
Baylor Scott and White Research Institute
Dallas, Texas, United States, 75231
Actively Recruiting
21
Kerwin Medical Center
Dallas, Texas, United States, 75231
Actively Recruiting
22
Dominion Medical Associates, Inc.
Richmond, Virginia, United States, 23219
Actively Recruiting
23
Island Health Authorities
Victoria, British Columbia, Canada, V8R 1J8
Actively Recruiting
24
Hamilton Health Sciences , Mcmaster University
Hamilton, Ontario, Canada, L8M 1W9
Actively Recruiting
25
Baycrest Academy for Research and Education , University of Toronto
Toronto, Ontario, Canada, ON M6A 2E1
Actively Recruiting
26
Douglas Hospital Research Center, McGill university
Montreal, Quebec, Canada, H4H 1R3
Actively Recruiting
27
Grupo de Neurociencias de Antioquia, Universidad de Antioquia
Medellín, Antioquia, Colombia
Active, Not Recruiting
28
Instituto Sanacoop
Bayamón, Bayamón, Puerto Rico, 00961
Completed
29
SCB Research Center Corp
Bayamón, Puerto Rico, Puerto Rico, 00961
Actively Recruiting
30
The Alliance, Medical Sciences Campus University of Puerto Rico
Rio Piedras, Puerto Rico, Puerto Rico, 00935
Actively Recruiting
Research Team
E
Evelyn Gutiérrez
CONTACT
M
Margarita Venegas
CONTACT
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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