Recruiting

Immunocal®

Sponsor:

Immunotec Inc.

Code:

NCT03448055

Conditions

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Immunocal

Study Details

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.

Conditions

Mild Cognitive Impairment (MCI)

Study ID

NCT03448055

Start date

Feb 5, 2018

Status verified date

Feb, 2021

Completion date

Nov 25, 2023

Anticipated

Primary completion date

Nov 25, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

This study is recruiting Mild Cognitive Impaired (MCI) patients from the Memory Clinic of the Jewish General Hospital only.

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Interventional

Immunocal 20gm daily

Interventions

Immunocal

cysteine-rich whey protein isolate

Primary outcome measure

  • Change in GSH levels in the brain [ Time Frame: Baseline compared to month 6 (180 days) ]

Central Contacts and Locations

Locations

Memory Clinic/Jewish General Hospital

Recruiting

Montréal, Quebec, Canada, H3T 1E2

Contacts

Chris Hosein, M.Ed, CCRP

514-340-8222chosein@jgh.mcgill.ca

Principal Investigator:

Hyman M. Schipper, MD, PhD, FRCPC

More Information

Sponsor

Immunotec Inc.

Last update posted

Feb 10, 2021

Last verified

Feb, 2021

Keywords

  • MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Immunotec Inc. on 2021-02-10.