Mild Cognitive Impairment (MCI)NCT03448055
Nutritional Intervention With the Dietary Supplement, Immunocal® in MCI Patients: Promotion of Brain Health
A study testing Immunocal in people with Mild Cognitive Impairment (MCI), run by Immunotec Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Immunocal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2018to 25 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Memory Clinic/Jewish General Hospital
Montreal, Quebec, H3T 1E2
Chris Hosein, M.Ed, CCRP, 514-340-8222 ext. 23621, chosein@jgh.mcgill.ca
Hyman M. Schipper, MD, PhD, FRCPC
About this study
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
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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Immunocal
- Keywords
- MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation
- Medical subject headings
- Cognitive Dysfunction, Glucocorticoid-Remediable Aldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunocalDietary supplement
cysteine-rich whey protein isolate
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Other | Immunocal 20gm daily Receives: Dietary Supplement: Immunocal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GSH levels in the brain
Change in cerebral Glutathione levels of MCI patients measured by MRI/MRS scans
Measured: Baseline compared to month 6 (180 days)
Secondary outcomes (2)
Change in plasma GSH:GSSG ratios measured by HPLC
To evaluate positive correlation between plasma GSH:GSSG ratios and changes in cerebral GSH
Measured: Baseline compared to month 6 (180 days)
Evaluation of neuropsychological and cognitive functions
The Memory Clinic of JGH Neuropsychological evaluation questionnaire will be used to measure both neuropsychological and cognitive functions
Measured: Baseline compared to month 6 (180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start5 Feb 2018
- Primary completion25 Nov 2022 (estimated)
- Study completion25 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Nutritional supplemetation with Immunocal 20gm daily for 6 months (180 days)
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunotec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448055
- Sponsor's protocol ID
- MCI-IMM15
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28603087Winter 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03448055
- Acronym / sponsor ID
- MCI-IMM15
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Immunotec Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 25 Nov 2022 (estimated)
- Study completion
- 25 Nov 2023 (estimated)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nutritional supplemetation with Immunocal 20gm daily for 6 months (180 days)
| Arm | Type | Receives |
|---|---|---|
| Interventional | Other | Dietary Supplement: ImmunocalImmunocal 20gm daily |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 55-85
- Male or female
- Non-smoker
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunocalcysteine-rich whey protein isolate | Dietary supplement | Interventional |
Primary outcome
Change in GSH levels in the brain
Time frame: Baseline compared to month 6 (180 days)
Change in cerebral Glutathione levels of MCI patients measured by MRI/MRS scans
2 secondary outcomes
Change in plasma GSH:GSSG ratios measured by HPLC
Time frame: Baseline compared to month 6 (180 days)
Evaluation of neuropsychological and cognitive functions
Time frame: Baseline compared to month 6 (180 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 28603087Song 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.
- Background: PubMed 28894506Winter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunocal in people with Mild Cognitive Impairment (MCI), run by Immunotec Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GSH levels in the brain (time frame: Baseline compared to month 6 (180 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448055, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.