IGC-AD1 Trial on Agitation in Dementia Due to AD

• Status: Enrolling by invitation
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a superiority, parallel group, double blinded, randomized, powered, multi-site, and placebo-controlled study.

Ages 60 and above Participants with mild to severe dementia due to Alzheimer's Disease, with established and persistent symptomatological Agitation, for a minimum of two weeks rather than those with Agitation due to other etiologies, or recent, or transient Agitation symptoms. This is established using the NPI-12 (Agitation Domain only ≥ 4) during the screening process.

Number or Participants:146 (73 for each arm) plus 10% dropout for a total of 164 Participants.

The length of treatment: 42 days Length of the Study: 50-57 days.

Study Drug:IGC-AD1 is a non-sterile solution for oral or sublingual administration. The oral solution contains 2 active ingredients, cannabis based, tetrahydrocannabinol (THC) and Melatonin.

Primary Objective: To assess the efficacy of IGC-AD1 in Participants with symptomatological Agitation associated with mild to severe dementia due to AD, in a six-week, placebo-controlled trial, using the CMAI.

Secondary Objective:To assess acute efficacy of IGC-AD1 on symptomatological Agitation, in dementia due to AD, in a two-week placebo-controlled trial using CMAI.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IGC Pharma LLC

Criteria

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria:

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 by the Caregiver as, among others a) Power of Attorney, or 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, Pharmacokinetics and storage of blood samples for future genetic testing.

6. Diagnosis of AD by NIA-AA criteria

7. Clinically significant Agitation assessed by:

1. NPI (Agitation) ≥ 4.

2. The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and

3. Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.

8. Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.

9. All medications used for behavioral symptoms should be in stable doses for at least 3 months before screening.

10. 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)).

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Prior adverse reaction to cannabinoids or to any component of study drug (IGC-AD1 and placebo): THC, melatonin, honey, curcumin, ethyl alcohol, vitamin-E TPGS, ascorbic acid, water, tween-80, and rutin.

2. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, 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 3 months before screening.

6. History of Alcohol and Drug use, excluding marijuana, 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 (the definition of recurrent falls is taken from AFP: ).