Clinical Trial on Agitation in Alzheimer's Dementia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden, NPS, Aggression

In brief

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 facts

Study ID: NCT05543681
Run by: IGC Pharma, LLC
People needed: 164
Starts: 2022-10-11
Expected to finish: 2026-08-01
Last updated by the study team: 2026-05-20

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

The Alliance, Medical Sciences Campus University of Puerto Rico — Rio Piedras, Puerto Rico (enrolling)
ClinCloud, LLC — Melbourne, Florida, United States (enrolling)
Central Miami Medical Institute — Miami, Florida, United States (enrolling)
Visionary Investigators Network — Miami, Florida, United States (enrolling)
Miami Jewish Health — Miami, Florida, United States (enrolling)
Neurostudies Inc. — Port Charlotte, Florida, United States (enrolling)
BayCare Health System Inc. — St. Petersburg, Florida, United States (enrolling)
University of South Florida Department of Psychiatry and Behavioral Neurosciences — Tampa, Florida, United States (enrolling)
Tandem Clinical Research GI, LLC — Metairie, Louisiana, United States (enrolling)
MedStar Franklin Square Medical Center Neurology — Baltimore, Maryland, United States (enrolling)
Medstar Southern Maryland Hospital Center — Clinton, Maryland, United States (enrolling)
Medstar Montgomery Medical Center — Olney, Maryland, United States (enrolling)
Tekton Research LLC — St Louis, Missouri, United States (enrolling)
Dent Neurologic Institute — Amherst, New York, United States (enrolling)
Integrative Clinical Trials, LLC — Brooklyn, New York, United States (enrolling)
Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
Ichor Research — Syracuse, New York, United States (enrolling)
Lynn Health Science Institute (LHSI) — Oklahoma City, Oklahoma, United States (enrolling)
Butler Hospital, Brown University — Providence, Rhode Island, United States (enrolling)
Senior Adults Specialty Research — Austin, Texas, United States (enrolling)
Baylor Scott and White Research Institute — Dallas, Texas, United States (enrolling)
Kerwin Medical Center — Dallas, Texas, United States (enrolling)
Dominion Medical Associates, Inc. — Richmond, Virginia, United States (enrolling)
Island Health Authorities — Victoria, British Columbia, Canada (enrolling)
Hamilton Health Sciences , Mcmaster University — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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