Study of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease

A Phase I Randomized Placebo Controlled MAD Study to Evaluate Safety and Tolerability of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease

A single center, randomized, placebo controlled multiple ascending dose study of IGC AD1 to evaluate safety and tolerability in subjects with dementia due to Alzheimer's Disease (AD).

Study Overview

• Status: Completed
• Conditions: Dementia of Alzheimer Type
• Intervention / Treatment: Drug: IGC AD1; Drug: Placebo

Detailed Description

This is a phase I Multiple Ascending Dose (MAD) study to evaluate safety and tolerability of IGC-AD1 in subjects with AD. Twelve subjects will be enrolled. Three different ascending doses of the study product will be given: low, medium and high doses. Each dose will be given for 2 weeks, followed by a washout period of 4 days. Given the vulnerability of the population, a safety cohort of 3 patients (2 active, 1 placebo) will start every dose one day ahead of the rest of the patients and will be followed for 24 hours for the development of Adverse Events (AEs). Objective criteria will be set after the safety cohort is evaluated.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico
    • Puerto Rico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient and/or study partner (relative) must provide a signed and dated Informed Consent form prior to any study procedures which will be discussed with the Study Coordinator.
2. Provision of a letter from the Neurologist/Psychiatrist/Internal Medicine Physician certifying the diagnosis of Alzheimer's Dementia and patient's ability to consent. If patient is unable to consent, only the legal guardian/tutor of the patient could consent in his/her behalf. The guardian/tutor will be required to present the pertinent legal documentation.
3. Must have a study partner who is able and willing to comply with all required study procedures.
4. Patient should meet NIA-AA criteria for Alzheimer's disease, any stage.
5. At least 3 months evolution of behavioral symptoms at screening visit.
6. Negative drug screen, except for benzodiazepines if patient has been using them in stable doses for at least 3 months before screening.
7. All medications used for behavioral symptoms should be in stable doses for at least 3 months before screening.
8. All medications used for other conditions besides behavioral symptoms should be at stable doses for at least 30 days before screening.
9. Women must be postmenopausal (defined as cessation of menses for at least 1 year) or surgically sterile (hysterectomy, oophorectomy or bilateral tubal ligation) at the time of screening.

Exclusion Criteria:

1. Prior adverse reaction to cannabinoids.
2. Prior contraindication or allergy to any component of study product (IGC-AD1): melatonin, honey, curcumin, ethyl alcohol, vitamin-E TPGS, ascorbic acid, water, tween-80, and rutin.
3. History of stroke, multiple sclerosis (MS), or epilepsy. History of gastrointestinal dysfunction not related to Alzheimer's disease (e.g., inflammatory bowel disease or gastrointestinal cancer)
4. Any clinically relevant neurological disorder capable of producing a dementia syndrome including Parkinson's disease, stroke, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, and others.
5. Other possible causes of dementia as: infections of the CNS (e.g. HIV, syphilis) or Creutzfeldt Jakob disease, subdural hematoma, communicating hydrocephalus, brain tumors, drug intoxication, alcohol intoxication, thyroid disease, parathyroid disease, and vitamin B12 or other deficiencies
6. Use of contraindicated medication (see section 6).
7. History of myocardial infarction, severe congestive heart failure, unstable angina, significant valvular disease, or cardiomyopathy within 1 year of screening.
8. History of cardiac arrhythmias, second or third-degree AV block.
9. History of seizures, schizophrenia, or bipolar disorder.
10. Other condition or clinically important abnormality on vital signs, physical examination, neurologic examination, laboratory results or electrocardiogram (ECG) examination that could compromise the study efficacy interpretation or safety of the subject.
11. Have participated in an investigational drug or device study within 30 days prior to study start.
12. TCA or opioid use within 30 days before the enrollment.
13. History of alcohol and drug abuse within 2 years of screening.
14. Elevated liver enzymes (AST or ALT ≥3 times upper limit of normal, Total bilirubin≥1.5 times ULN or ALP≥1.5 times ULN).
15. Urine drug screen positive for drug use, except for benzodiazepines if patient was using them previously and their dose had remained stable for at least 3 months before screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; IGC AD1	Drug: IGC AD1; IGC AD1 oral Solution
Placebo Comparator: Placebo; IGC AD1 Placebo	Drug: Placebo; Placebo of IGC AD1 oral Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events in IGC-AD1 as compared to placebo [Safety and Tolerability]	Evaluate safety and tolerability of IGC AD1 10 participants will be administered the investigational drug and two will be administered placebo. Incidence of treatment emergent adverse events will be assessed to determine safety and tolerability of IGC-AD1.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of efficacy using Neuropsychiatric Inventory (NPI) scale	Secondary Outcome: Comparison of the measurement of Neuropsychiatric Inventory (NPI) scale changes from baseline using the Suicide Severity Rating Scale (C-SSRS)	3 weeks

Collaborators and Investigators

• Sponsor: IGC Pharma LLC
• Investigators: Study Director: IGC Pharma INC, IGC Pharma INC

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): June 20, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: P1 IGC-AD1 BPSD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No