ClinicalTrials.gg
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has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 223 studies in Cognitive Dysfunction with a site in Canada — 60 open to participants now, 79 under way, 7 of them phase 3. Cognitive Dysfunction · Canada.

Planned enrollment
133rd of 170
25 · median 62
Started
2018
with 19 others
No phase
115 of 223
36 open now
Registered
80th of 223
by date

Among the 223 studies in Cognitive Dysfunction with a site in Canada, this one is the 133rd largest by planned enrollment of the 170 interventional ones that give a count, is one of 20 that started in 2018, is one of 115 with no phase, and was the 80th registered.

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

Browse Cognitive Dysfunction studies →

Open to participants now

60 of the 223 studies in Cognitive Dysfunction with a site in Canada are open now. Recruiting first, the newest first:

55 more — sign in →

All 60 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.

This study: 55 Years to 85 Years · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Mild Cognitive Impairment (MCI)

Keywords

  • MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

06

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)

07

Study locations

1 of 1 sites recruiting
  • Memory Clinic/Jewish General Hospital
    Montréal, Quebec H3T 1E2, Canada
    Recruiting
    • Chris Hosein, M.Ed, CCRP · Contactchosein@jgh.mcgill.ca · 514-340-8222
    • Hyman M. Schipper, MD, PhD, FRCPC · Principal investigator
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Nov 2022, 57 months after the start.

Of 69 industry-sponsored interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 57 months is above that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2018
First posted
Feb 27, 2018
StartActual
Feb 5, 2018
Primary completionEst.
Nov 25, 2022
CompletionEst.
Nov 25, 2023
Last update
Feb 10, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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Discussion

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Studies of the drug tested here: Whey Protein Isolate

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