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

Primary Purpose

Mild Cognitive Impairment (MCI)

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Immunocal

About this trial

This is an interventional health services research trial for Mild Cognitive Impairment (MCI) focused on measuring MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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, 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

Sites / Locations

Memory Clinic/Jewish General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interventional

Arm Description

Immunocal 20gm daily

Outcomes

Primary Outcome Measures

Change in GSH levels in the brain

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

Secondary Outcome Measures

Change in plasma GSH:GSSG ratios measured by HPLC

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

Evaluation of neuropsychological and cognitive functions

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

Full Information

NCT ID

NCT03448055

First Posted

February 6, 2018

Last Updated

February 9, 2021

Sponsor

Immunotec Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03448055

Brief Title

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

Official Title

Nutritional Intervention With the Cysteine-rich Whey Protein Isolate Dietary Supplement Immunocal® in MCI Patients: Promotion of Brain Health & Wellness During Aging and Oxidative Stress

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 5, 2018 (Actual)

Primary Completion Date

November 25, 2022 (Anticipated)

Study Completion Date

November 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immunotec Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment (MCI)

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Nutritional supplemetation with Immunocal 20gm daily for 6 months (180 days)

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interventional

Arm Type

Other

Arm Description

Immunocal 20gm daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Immunocal

Intervention Description

cysteine-rich whey protein isolate

Primary Outcome Measure Information:

Title

Change in GSH levels in the brain

Description

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

Time Frame

Baseline compared to month 6 (180 days)

Secondary Outcome Measure Information:

Title

Change in plasma GSH:GSSG ratios measured by HPLC

Description

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

Time Frame

Baseline compared to month 6 (180 days)

Title

Evaluation of neuropsychological and cognitive functions

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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: 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, 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

Facility Information:

Facility Name

Memory Clinic/Jewish General Hospital

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chris Hosein, M.Ed, CCRP

Phone

514-340-8222

Ext

23621

chosein@jgh.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Hyman M. Schipper, MD, PhD, FRCPC

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28603087

Citation

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.

Results Reference

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PubMed Identifier

28894506

Citation

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.

Results Reference

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Learn more about this trial

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

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