Mild Cognitive Impairment (MCI)
Conditions
Keywords
MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation
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.
Interventions
DIETARY_SUPPLEMENTImmunocal
cysteine-rich whey protein isolate
Sponsors
Immunotec Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Nutritional supplemetation with Immunocal 20gm daily for 6 months (180 days)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed