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Status unknownNCT03448055Updated Feb 10, 2021

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

An interventional study of Immunocal in Mild Cognitive Impairment (MCI), sponsored by Immunotec Inc.. Status unknown at 1 site in Canada. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Immunotec Inc. · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
55 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Mild Cognitive Impairment (MCI)

Keywords

  • MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation
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Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Inclusion criteria

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Other
    Interventional

    Immunocal 20gm daily

    Dietary Supplement: Immunocal

Interventions

  • Dietary supplementImmunocal

    cysteine-rich whey protein isolate

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What researchers measure

Primary outcomes

  1. Change in GSH levels in the brain

    Change in cerebral Glutathione levels of MCI patients measured by MRI/MRS scans

    Time frame: Baseline compared to month 6 (180 days)

Secondary outcomes

  1. Change in plasma GSH:GSSG ratios measured by HPLC

    To evaluate positive correlation between plasma GSH:GSSG ratios and changes in cerebral GSH

    Time frame: Baseline compared to month 6 (180 days)

  2. Evaluation of neuropsychological and cognitive functions

    The Memory Clinic of JGH Neuropsychological evaluation questionnaire will be used to measure both neuropsychological and cognitive functions

    Time frame: Baseline compared to month 6 (180 days)

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Study locations

1 of 1 sites recruiting
  • Memory Clinic/Jewish General Hospital
    Montréal, Quebec H3T 1E2, Canada
    • Chris Hosein, M.Ed, CCRP · Contact · chosein@jgh.mcgill.ca · 514-340-8222
    • Hyman M. Schipper, MD, PhD, FRCPC · Principal investigator
    Recruiting
07

References and documents

Publications

  • Song W, Tavitian A, Cressatti M, Galindez C, Liberman A, Schipper HM. Cysteine-rich whey protein isolate (Immunocal(R)) ameliorates deficits in the GFAP.HMOX1 mouse model of schizophrenia. Free Radic Biol Med. 2017 Sep;110:162-175. doi: 10.1016/j.freeradbiomed.2017.05.025. Epub 2017 Jun 8. PubMed 28603087 ↗
  • Winter AN, Ross EK, Daliparthi V, Sumner WA, Kirchhof DM, Manning E, Wilkins HM, Linseman DA. A Cystine-Rich Whey Supplement (Immunocal(R)) Provides Neuroprotection from Diverse Oxidative Stress-Inducing Agents In Vitro by Preserving Cellular Glutathione. Oxid Med Cell Longev. 2017;2017:3103272. doi: 10.1155/2017/3103272. Epub 2017 Aug 15. PubMed 28894506 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03448055
Lead sponsor
Immunotec Inc.
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Feb 5, 2018
Primary completion
Nov 25, 2022 (estimated)
Completion
Nov 25, 2023 (estimated)
Last update
Feb 10, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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