IGC-AD1 Trial on Agitation in Dementia Due to Alzheimer's

Depression Clinical Trial

— IGC-AD1-P2  

Official title:

A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants With Dementia Due to Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543681
• Other study ID #: IGC-AD1-P2 BIDAG
• Status: Recruiting
• Phase: Phase 2
• Start date: October 11, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: India Globalization Capital Inc
• Contact: Evelyn Gutierrez
• Phone: 3013394270
• Email: egutierrez[@]igcpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of an oral medication, IGC-AD1 that is a natural THC-based (Tetrahydrocannabinol) formulation, administered in micro doses, twice a day, on symptomatological Agitation, in patients with mild to severe dementia from Alzheimer's.

Description:

This is a placebo-controlled, multi-site, parallel, double blind, randomized study. Enrollment is open for Participants ages 60 and above with mild to severe dementia due to Alzheimer's Disease, with established symptomatological Agitation, for a minimum of two weeks prior to enrollment, with Agitation due to other etiologies, or recent, or transient Agitation symptoms ruled out. Clinical Agitation is established with a baseline NPI-12 (Agitation Domain only) score ≥ 4 as well as meeting the IPA criteria for Agitation.

The medication is titrated to BID over two days and down over two days at End of Trial (EOT). Caregivers will monitor and record in a logbook vitals daily using Sponsor provided scales and logbook.

Safety will be monitored with daily calls to the Participant/Caregiver dyad for the first four days followed by calls every third day till EOT. Week two is an on-site visit with week-four being optional.

Both solicited AEs and non-solicited AEs will be monitored, assessed, graded, and tabulated. Solicited AEs include the following: somnolence, falls, dizziness, asthenia, nausea, suicidal ideation, tachycardia, bradycardia, hypertension and hypotension, and BMI.

The primary objective of the study is to assess the efficacy of IGC-AD1 on Agitation as scored by the CMAI between baseline and EOT with the secondary objective being acute efficacy as measured by the CMAI between baseline and week two. There are several exploratory objectives included elsewhere. The trial will also have blood draws for sparse Pharmacokinetics (PK).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Inclusion 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 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

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 consistent for at least 3 months before screening, with allowance for dose changes up to 25%.

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)).

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

Exclusion Criteria

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, 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 3 months 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).

Related Conditions & MeSH terms

• Aggression
• Agitated; State, Acute Reaction to Stress
• Agitation,Psychomotor
• Alzheimer Disease
• Anxiety
• Caregiver Burden
• Dementia
• Depression
• Memory Impairment
• Psychomotor Agitation
• Stress Disorders, Traumatic, Acute

Intervention

Drug:
• Agitation management in Alzheimer's disease (IGC-AD1-Active)
A non-sterile solution for oral administration.
• Agitation management in Alzheimer's disease (IGC-AD1-Placebo)
A non-sterile solution for oral administration similar in color and texture to the Active.

Locations

Country	Name	City	State
Canada	Site 300	Montréal	Quebec
Canada	Site 1000	Toronto	Ontario
Puerto Rico	Site 100	Bayamón
Puerto Rico	Site 200	Bayamón
Puerto Rico	Site 500	Rio Piedras
United States	Site 900	Amherst	New York
United States	Site 400	Baltimore	Maryland
United States	Site 700	Melbourne	Florida
United States	Site 1200	Miami	Florida
United States	Site 800	Newton	Massachusetts
United States	Site 1100	Port Charlotte	Florida

Sponsors (1)

Lead Sponsor	Collaborator
IGC Pharma LLC

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Agitation at week four	Change in mean Cohen Mansfield Agitation Inventory (CMAI) score	Baseline to week four
Other	Participant overall wellbeing	Change in the Clinical Global Impression Scale (CGI)	Baseline to weeks two and six
Other	Participant executive functions	Change in Mini-Mental State Examination (MMSE2) score	Baseline to week six
Other	Depression	Change in mean Cornell Scale for Depression in Dementia (CSDD) score	Baseline to weeks two, four, and six
Other	Neuropsychiatric symptoms	Change in mean Neuropsychiatric Inventory (NPI-12) score	Baseline to weeks two, four, and six
Other	Participant quality of life	Change in mean Quality of Life in Alzheimer's Disease (QOL-AD) score	Baseline to weeks two, four and six
Other	Caregiver burden	Change in mean Zarit Burden Interview (ZBI) score	Baseline to weeks two and six
Other	Psychotropic drugs	Change in type and dosage of psychotropic drugs	Baseline to six weeks
Other	CYP2C9 polymorphisms on agitation	Change in mean Cohen Mansfield Agitation Inventory (CMAI) score for each type of metabolizer group (*1/*1, *1/*3, etc.)	Baseline to weeks two, four and six
Primary	Agitation	Change in mean Cohen Mansfield Agitation Inventory (CMAI) score	Baseline to week six
Secondary	Acute Agitation	Change in mean Cohen Mansfield Agitation Inventory (CMAI) score	Baseline to week two