RecruitingAlzheimer DiseaseAgitation,PsychomotorCare Giving Burden

Clinical Trial on Agitation in Alzheimer's Dementia

Eligible age

60+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: IGC Pharma, LLC

You may qualify if…

✓ 1. Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures.
✓ 2. Must have a Caregiver who is able and willing to comply with all required study procedures.
✓ 3. 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.
✓ 4. 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.
✓ 5. Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.
✓ 6. Diagnosis of AD by NIA-AA criteria
✓ 7. Clinically significant Agitation assessed by:
✓ 1. NPI (Agitation) ≥ 4

You may not qualify if…

✕ 1. Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).
✕ 2. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which might confound assessment of safety outcomes.
✕ 3. History of seizures, schizophrenia, or bipolar disorder.
✕ 4. Has participated in an investigational drug or device study within 30 days prior to study start.
✕ 5. 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.
✕ 6. History of Alcohol and Drug use disorder, within one year prior to enrollment.
✕ 7. 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.
✕ 8. 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).