Clinical Trial on Agitation in Alzheimer's Dementia

NCT05543681 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IGC-AD1-P2 BIDAG
• Study Type: interventional
• Target: 164
• Locations: 4 countries
• Sites: 30

Brief Summary

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

Alzheimer Disease; Agitation,Psychomotor; Care Giving Burden; NPS; Aggression

Keywords

Cannabis; Tetrahydrocannabinol; THC; Melatonin; Alzheimer's; Marijuana; Hemp; Agitation; Dementia; Depression; Anxiety; NPI; CMAI; Dronabinol

Outcome Measures

Primary Outcomes (1)

• Agitation

  Change in mean Cohen Mansfield Agitation Inventory (CMAI) score

  Baseline to week six

Secondary Outcomes (1)

• Acute Agitation

  Baseline to week two

Other Outcomes (9)

• Agitation at week four

  Baseline to week four

• Participant overall wellbeing

  Baseline to weeks two and six

• Participant executive functions

  Baseline to week six

Study Arms (2)

Active Comparator: IGC-AD1Active

ACTIVE COMPARATOR

IGC-AD1-Active, oral solution with two APIs (THC and melatonin).

Drug: IGC-AD1-Active

Placebo Comparator: IGC-AD1 Placebo

PLACEBO COMPARATOR

IGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs.

Drug: IGC-AD1-Placebo

Interventions

IGC-AD1-Active DRUG

A non-sterile solution for oral administration.

Also known as: Active

Active Comparator: IGC-AD1Active

IGC-AD1-Placebo DRUG

A non-sterile solution for oral administration similar in color and texture to the Active.

Also known as: Placebo

Placebo Comparator: IGC-AD1 Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures.
• Must have a Caregiver who is able and willing to comply with all required study procedures.
• The Caregiver must be known to the Participant and must be able to use electronic devices such as a cell phone, video conference over a laptop or cell phone, weighing scale, and be able to learn to take blood pressure, among others.
• Based on local practice, Participants that cannot consent may have Caregiver's consent provided the Caregiver has among others a) Power of Attorney, b) is a spouse, or c) a sibling or d) a child or e) a close relation. The practice of accepting consent must be consistent with established practice at the site and jurisdiction.
• Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.
• Diagnosis of AD by NIA-AA criteria
• Clinically significant Agitation assessed by:
• NPI (Agitation) ≥ 4
• The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and
• Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.
• Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.
• All medications used for behavioral symptoms should be consistent for at least 6 weeks before screening, with allowance for dose changes up to 25%.
• Women must be of no childbearing potential (postmenopausal, defined as cessation of menses for at least 12 months, without an alternative medical cause for amenorrhea) or surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)).
• An individual who meets any of the following criteria will be excluded from participation in this study:

You may not qualify if:

• Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).
• Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which might confound assessment of safety outcomes.
• History of seizures, schizophrenia, or bipolar disorder.
• Has participated in an investigational drug or device study within 30 days prior to study start.
• Urine drug screen positive for drug use, except for benzodiazepines if Participant was using them previously and their dose had remained stable for at least six weeks before screening.
• History of Alcohol and Drug use disorder, within one year prior to enrollment.
• Hypertension: Participants with a history of uncontrolled hypertension as determined by the PI and Participants with a hypertensive crisis in the six months prior to enrollment.
• Falls: Participants with a history of recurrent falls defined as more than two falls in the six-month period prior to enrollment and a history of falls resulting in injuries or associated with a new acute illness, loss of consciousness, fever, or abnormal blood pressure (Fuller et al., 2000).

Sponsors & Collaborators

• IGC Pharma, LLC: lead

Study Sites (30)

ClinCloud, LLC

Maitland, Florida, 32751, United States

ACTIVE NOT RECRUITING

ClinCloud, LLC

Melbourne, Florida, 32940, United States

RECRUITING

Central Miami Medical Institute

Miami, Florida, 33125, United States

RECRUITING

Visionary Investigators Network

Miami, Florida, 33133, United States

RECRUITING

Miami Jewish Health

Miami, Florida, 33137, United States

RECRUITING

Neurostudies Inc.

Port Charlotte, Florida, 33952, United States

RECRUITING

BayCare Health System Inc.

St. Petersburg, Florida, 33705, United States

RECRUITING

University of South Florida Department of Psychiatry and Behavioral Neurosciences

Tampa, Florida, 33613, United States

RECRUITING

Tandem Clinical Research GI, LLC

Metaire, Louisiana, 70006, United States

RECRUITING

MedStar Franklin Square Medical Center Neurology

Baltimore, Maryland, 21237, United States

RECRUITING

Medstar Southern Maryland Hospital Center

Clinton, Maryland, 20735, United States

RECRUITING

Medstar Montgomery Medical Center

Olney, Maryland, 20832, United States

RECRUITING

Tekton Research LLC

St Louis, Missouri, 63128, United States

RECRUITING

Dent Neurologic Institute

Amherst, New York, 02459, United States

RECRUITING

Integrative Clinical Trials, LLC

Brooklyn, New York, 11229, United States

NOT YET RECRUITING

Ichor Research

Syracuse, New York, 13210, United States

RECRUITING

Lynn Health Science Institute (LHSI)

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Butler Hospital, Brown University

Providence, Rhode Island, 02906, United States

RECRUITING

Senior Adults Specialty Research

Austin, Texas, 78757, United States

RECRUITING

Baylor Scott and White Research Institute

Dallas, Texas, 75231, United States

RECRUITING

Kerwin Medical Center

Dallas, Texas, 75231, United States

RECRUITING

Dominion Medical Associates, Inc.

Richmond, Virginia, 23219, United States

RECRUITING

Island Health Authorities

Victoria, British Columbia, V8R 1J8, Canada

RECRUITING

Hamilton Health Sciences , Mcmaster University

Hamilton, Ontario, L8M 1W9, Canada

RECRUITING

Baycrest Academy for Research and Education , University of Toronto

Toronto, Ontario, ON M6A 2E1, Canada

RECRUITING

Douglas Hospital Research Center, McGill university

Montreal, Quebec, H4H 1R3, Canada

RECRUITING

Grupo de Neurociencias de Antioquia, Universidad de Antioquia

Medellín, Antioquia, Colombia

ACTIVE NOT RECRUITING

Instituto Sanacoop

Bayamón, Bayamón, 00961, Puerto Rico

COMPLETED

SCB Research Center Corp

Bayamón, Puerto Rico, 00961, Puerto Rico

RECRUITING

The Alliance, Medical Sciences Campus University of Puerto Rico

Rio Piedras, Puerto Rico, 00935, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation; Caregiver Burden; Aggression; Marijuana Abuse; Dementia; Depression; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Stress, Psychological; Social Behavior; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Evelyn Gutiérrez

CONTACT

+13013394270; calma@igcpharma.com

Margarita Venegas

CONTACT

mvenegas@igcpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind for study site and participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-site, Randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to severe dementia from Alzheimer's and symptomatological Agitation.

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: October 11, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); CO (1); PR (3); US (22)