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

NCT04749563 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: P1 IGC-AD1 BPSD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dementia of Alzheimer Type

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of efficacy using Neuropsychiatric Inventory (NPI) scale

  3 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

IGC AD1

Drug: IGC AD1

Placebo

PLACEBO COMPARATOR

IGC AD1 Placebo

Drug: Placebo

Interventions

IGC AD1 DRUG

IGC AD1 oral Solution

Active

Placebo DRUG

Placebo of IGC AD1 oral Solution

Placebo

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Must have a study partner who is able and willing to comply with all required study procedures.
• Patient should meet NIA-AA criteria for Alzheimer's disease, any stage.
• At least 3 months evolution of behavioral symptoms at screening visit.
• Negative drug screen, except for benzodiazepines if patient has been using them in stable doses for at least 3 months before screening.
• All medications used for behavioral symptoms should be in stable doses for at least 3 months before screening.
• All medications used for other conditions besides behavioral symptoms should be at stable doses for at least 30 days before screening.
• 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.

You may not qualify if:

• Prior adverse reaction to cannabinoids.
• 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.
• 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)
• 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.
• 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
• Use of contraindicated medication (see section 6).
• History of myocardial infarction, severe congestive heart failure, unstable angina, significant valvular disease, or cardiomyopathy within 1 year of screening.
• History of cardiac arrhythmias, second or third-degree AV block.
• History of seizures, schizophrenia, or bipolar disorder.
• 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.
• Have participated in an investigational drug or device study within 30 days prior to study start.
• TCA or opioid use within 30 days before the enrollment.
• History of alcohol and drug abuse within 2 years of screening.
• Elevated liver enzymes (AST or ALT ≥3 times upper limit of normal, Total bilirubin≥1.5 times ULN or ALP≥1.5 times ULN).
• 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

Sponsors & Collaborators

• IGC Pharma, LLC: lead

Study Sites (1)

Puerto Rico

San Juan, Puerto Rico

Location

Study Officials

• IGC Pharma INC

  IGC Pharma INC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study subjects will be blinded to the treatment
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 dose escalation cohorts in same 12 subjects (5:1 randomization (active:placebo)

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: February 11, 2021
• Study Start: January 11, 2021
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)