Nutritional Intervention With the Dietary Supplement, Immunocal® in MCI Patients: Promotion of Brain Health

Not Applicable

• Conditions: Mild Cognitive Impairment (MCI)
• Interventions: Dietary Supplement: Immunocal

• Registration Number: NCT03448055
• Lead Sponsor: Immunotec Inc.

Brief Summary

Alzheimer disease (AD) is a dementing illness characterized by progressive neuronal degeneration, gliosis, and the accumulation of intracellular inclusions and extracellular deposits of amyloid in discrete regions of the basal forebrain, hippocampus, and the association cortices. Mild cognitive impairment (MCI) refers to individuals with cognitive impairment (often memory loss) that fails to meet clinical criteria for AD or another dementing illness.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-02-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10
• Primary Completion: 2022-11-25
• Study Completion: 2023-11-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Subjects meeting diagnostic criteria for MCI:

• Age 55-85
• Male or female
• Non-smoker

To ensure that the subject can physically fit in the scanner:

1. body weight ≤ 120 kg and
2. with a linear dimension max 55cm (shoulders or belly) Expected to remain in the greater Montreal area for the duration of study.

Exclusion Criteria

• Presence of an active, systemic illness (e.g., cancer, rheumatoid arthritis, etc.) or other chronic neurological (e.g. Parkinson's disease, multiple sclerosis) or psychiatric (e.g. major depression, schizophrenia) disease.
• Subjects taking other experimental medications or psychotropic agents.
• Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
• Ambulatory subjects: As wheelchair-bound subjects present additional difficulties for transportation and MRI scanning.

Musculoskeletal abnormalities that preclude the ability of the subject to lie on his/her back for 1hr during MRI scanning.

• Subjects who have a protein restricted diet as per their medical history.
• Pregnancy
• Subjects using N-acetylcysteine, α-lipoic acid supplements, other whey protein supplements or Vitamin C, within 2 months of enrolment and during the entire 6 months study period.
• Allergies to milk proteins/ Milk protein intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	Immunocal	Immunocal 20gm daily

Primary Outcome Measures

Name	Time	Method
Change in GSH levels in the brain	Baseline compared to month 6 (180 days)	Change in cerebral Glutathione levels of MCI patients measured by MRI/MRS scans

Secondary Outcome Measures

Name	Time	Method
Change in plasma GSH:GSSG ratios measured by HPLC	Baseline compared to month 6 (180 days)	To evaluate positive correlation between plasma GSH:GSSG ratios and changes in cerebral GSH
Evaluation of neuropsychological and cognitive functions	Baseline compared to month 6 (180 days)	The Memory Clinic of JGH Neuropsychological evaluation questionnaire will be used to measure both neuropsychological and cognitive functions

Trial Locations

Locations (1)

Memory Clinic/Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada