Status:
UNKNOWN
Nutritional Intervention With the Dietary Supplement, Immunocal® in MCI Patients: Promotion of Brain Health
Lead Sponsor:
Immunotec Inc.
Conditions:
Mild Cognitive Impairment (MCI)
Eligibility:
All Genders
55-85 years
Phase:
NA
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 dis...
Eligibility Criteria
Inclusion
- This study is recruiting Mild Cognitive Impaired (MCI) patients from the Memory Clinic of the Jewish General Hospital only.
- 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:
- body weight ≤ 120 kg and
- with a linear dimension max 55cm (shoulders or belly) Expected to remain in the greater Montreal area for the duration of study.
Exclusion
- 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
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 25 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03448055
Start Date
February 5 2018
End Date
November 25 2023
Last Update
February 10 2021
Active Locations (1)
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1
Memory Clinic/Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2