- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03612752
CMI-168 on Cognitive Function in Healthy Middle-aged Men and Women
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of a Peptide-protein Extract (CMI-168) on Cognitive Function in Healthy Middle-aged Men and Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study participation will last approximately 14 weeks, comprising of up to 4 weeks for screening, 8 weeks-blinded supplementation period and 2 weeks post-supplementation period. During the 8 weeks period, subjects will take either 2 study tablets of CMI-168 or 2 tablets of matching placebo once daily in the morning. Supplementation will be stopped after 56 days and after another 14 days, subjects will be re-assessed.
Key assessment of the screening period will be the cognitive testing using the Cambridge Neuropsychological Test Automated Battery (CANTAB) to ensure that the subjects fall within the normal cognitive range for their ages. The study aims to only include subjects with normal cognition and showing no perceptible signs of cognitive impairment at screening (Visit 1). Subjects showing cognition abnormal cognition scores during the screening stage by the CANTAB assessment will not be included in the next stages of the study. After a screening period of 3 to 28 days, eligible subjects will be randomized 1:1 ratio to two treatment arms.
- CMI-168 (2 tablet, once daily, 56 days).
- Placebo (2 tablets once daily, 56 days)
Following randomisation,the various assessments including cognitive tests, questionnaires, event related potential and blood samples will be administered or taken at Visit 2 (Baseline, start of supplementation), Visit 3 (Day 28 supplementation) and Visit 4 (Day 56 supplementation) and Visit 5 (Day 70-2 weeks after termination of supplementation). Subject completion of the study will be defined as completing the assessments at Visit 5. The different tests will be administered according to the schedule of assessments below.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan, 23561
- Recruiting
- Taipei Medical University - Shuang Ho Hospital
-
Contact:
- Dean Wu, PhD
- Phone Number: 886-9-70746912
- Email: tingyu02139@gmail.com
-
Contact:
- Chaurjong Hu, MD
- Phone Number: 886-9-70746908
- Email: chaurjongh@tmu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Institutional Review Board approved written informed consent and privacy language as per national regulations must be obtained from the patient or legally authorized representative prior to any clinical study-related procedures
- Subject is an otherwise healthy male/female between 35-65 years of age during the study period.
- Patient has a body mass index range of 18.0 to 40.0 kg/m2, inclusive, and weighs at least 40 kg at screening
- Patient agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the study.
- Ability to understand and write Taiwanese Traditional Chinese or at least have completed Taiwan high school education
- Perceived Stress Scale Score> 20
- Within normal cognition range as assessed by CANTAB battery
Exclusion Criteria:
- Inability to participate in the evaluation of the study
- Subject is pregnant at the time of the screening assessment
- Active viral infection or bacterial infection based on clinical observations
- Visual or hearing impairment sufficient to preclude cooperation with neurocognitive testing
- Long-term consumption of dietary supplement or herbal products likely to have an effect on memory
- Subjects intolerant or allergic to protein-based food or supplement
- Subjects with significant cognitive impairment including already being diagnosed with Alzheimer's disease, Parkinson's disease, schizophrenia or dementia.
- History of cardiovascular disease, respiratory disease, head injury, cancer, diabetes or neuropsychological disease
- Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing
- Psychological or linguistic incapability to sign the informed consent
- Anti-depressant treatment stopped since less than 3 months or still ongoing
- History of allergy to chicken meat
- Pregnant or lactating women
- Smoking more than 10 cigarettes per day
- Suspected or known alcohol abuse or addiction
- Subjects with any other conditions or diseases that investigator consider as not appropriate to be entered in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo arm
Placebo
|
Placebo
|
Experimental: Active arm
CMI-168
|
Dietary supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Cognitive function
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
Cambridge Neuropsychological Test Automated Battery (CANTAB)
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of Word Lists Subtest of the Weschler Memory Scale 3rd edition
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
Word Lists Subtest of the Weschler Memory Scale 3rd edition
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of Logical Memory Subtest of Weschler Memory Scale 3rd edition
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
Logical Memory Subtest of Weschler Memory Scale 3rd edition
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of Family Pictures Subtest of Weschler Memory Scale 3rd edition
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
Family Pictures Subtest of Weschler Memory Scale 3rd edition
|
From Day 0 to Day 28, Day 56 and Day 70
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of serum ALT
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum ALT
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serum AST
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum AST
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serum BUN
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum BUN
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serum creatinin
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum creatinin
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serum T3
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum T3
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serum T4
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum T4
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serum TSH
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum TSH
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serum cortisol at 8 am
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum cortisol at 8 am
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serum fasting sugar
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum fasting sugar
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of Event related potential P300
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
Event related potential P300
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of Perceived Stress Scale (PSS)
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
Perceived Stress Scale (PSS)
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of State-Trait Anxiety Inventory (STAI)
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
State-Trait Anxiety Inventory (STAI)
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of Beck Depression Inventory (BDI)
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
Beck Depression Inventory (BDI)
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of Pittsburgh Sleep Quality Index (PSQI)
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
Pittsburgh Sleep Quality Index (PSQI)
|
From Day 0 to Day 28, Day 56 and Day 70
|
Change of serun brain-derived neurotrophic factor (BDNF)
Time Frame: From Day 0 to Day 28, Day 56 and Day 70
|
serum brain-derived neurotrophic factor (BDNF)
|
From Day 0 to Day 28, Day 56 and Day 70
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chaurjong Hu, MD, Taipei Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- N201711060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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