Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CMI-168 on Cognitive Function in Healthy Middle-aged Men and Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03612752
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Chaurjongh Hu, Cerebos Pacific Limited

Brief Summary:
The investigators propose to conduct the present study in order to primarily assess the effects of CMI-168 in neurocognition enhancement. Studies have shown that episodic memory performance is declined in elder populations showing elevated cortisol levels and cognitive decline is accelerated with greater levels of self-reporting perceived stress . Additionally, stress-related disorders such as depression and anxiety adversely affect and impair cognitive function. Given the significant role of chronic stress, sleep, depression and anxiety in impairing memory and learning performance, questionnaires used to measure the following parameters of stress (Perceived Stress Scale, PSS), sleep (Pittsburg Sleep Quality Index, PSQI), anxiety (State-Trait Anxiety Inventory, STAI) and depression (Beck Depression Inventory, BDI) have been incorporated into this study design. Additionally, levels of Brain-Derived Neurotrophic Factor (BDNF), a protein involved in neuronal survival and synaptic plasticity of the central and peripheral nervous system, have been reported to be significantly different in patients with depression or neurological disorders . The investigators will also examine the physiological levels of cortisol and BDNF in these subjects to determine their effect of CMI-168 supplementation on these measures, as well as the implications on cognition.

Condition or disease Intervention/treatment Phase
Cognitive Change Dietary Supplement: CMI-168 Other: Placebo Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 31, 2019

Arm Intervention/treatment
Experimental: Active arm
CMI-168
Dietary Supplement: CMI-168
Dietary supplement

Placebo Comparator: Placebo arm
Placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Change of Cognitive function [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    Cambridge Neuropsychological Test Automated Battery (CANTAB)

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Change of serum ALT [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    serum ALT

  2. Change of serum AST [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    serum AST

  3. Change of serum BUN [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    serum BUN

  4. Change of serum creatinin [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    serum creatinin

  5. Change of serum T3 [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    serum T3

  6. Change of serum T4 [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    serum T4

  7. Change of serum TSH [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    serum TSH

  8. 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

  9. Change of serum fasting sugar [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    serum fasting sugar

  10. Change of Event related potential P300 [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    Event related potential P300

  11. Change of Perceived Stress Scale (PSS) [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    Perceived Stress Scale (PSS)

  12. 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)

  13. Change of Beck Depression Inventory (BDI) [ Time Frame: From Day 0 to Day 28, Day 56 and Day 70 ]
    Beck Depression Inventory (BDI)

  14. 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)

  15. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612752


Contacts
Layout table for location contacts
Contact: Dean Wu, PhD 886-9-70746912 tingyu02139@gmail.com
Contact: Chaurjong Hu, MD 886-9-70746908 chaurjongh@tmu.edu.tw

Locations
Layout table for location information
Taiwan
Taipei Medical University - Shuang Ho Hospital Recruiting
New Taipei City, Taiwan, 23561
Contact: Dean Wu, PhD    886-9-70746912    tingyu02139@gmail.com   
Contact: Chaurjong Hu, MD    886-9-70746908    chaurjongh@tmu.edu.tw   
Sponsors and Collaborators
Cerebos Pacific Limited
Investigators
Layout table for investigator information
Principal Investigator: Chaurjong Hu, MD Taipei Medical University

Layout table for additonal information
Responsible Party: Chaurjongh Hu, Professor, Cerebos Pacific Limited
ClinicalTrials.gov Identifier: NCT03612752     History of Changes
Other Study ID Numbers: N201711060
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chaurjongh Hu, Cerebos Pacific Limited:
Chicken essence, cognitive function