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

  • STATUS
    Recruiting
  • End date
    Nov 25, 2023
  • participants needed
    25
  • sponsor
    Immunotec Inc.
Updated on 19 February 2021

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.

Details
Condition Mild Cognitive Impairment, Mild Neurocognitive Disorder
Treatment Immunocal
Clinical Study IdentifierNCT03448055
SponsorImmunotec Inc.
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 55 yrs and 85 yrs?
Gender: Male or Female
Do you have Mild Cognitive Impairment?
Do you have any of these conditions: Mild Cognitive Impairment or Mild Neurocognitive Disorder?
Do you have any of these conditions: Mild Neurocognitive Disorder or Mild Cognitive Impairment?
Do you have any of these conditions: Mild Cognitive Impairment or Mild Neurocognitive Disorder?
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 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, -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
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