Cognitive ChangeNCT03612752
CMI-168 on Cognitive Function in Healthy Middle-aged Men and Women
A study testing CMI-168 in people with Cognitive Change, run by Cerebos Pacific Limited at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- CMI-168
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jun 2018to 31 Mar 2019
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
Dean Wu, PhD, 886-9-70746912, tingyu02139@gmail.com
Chaurjong Hu, MD, 886-9-70746908, chaurjongh@tmu.edu.tw
About this study
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
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.
Read the 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.
- Conditions
- Cognitive Change
- Being tested
- CMI-168, Placebo
- Keywords
- Chicken essence, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMI-168Dietary supplement
Dietary supplement
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | CMI-168 Receives: Dietary Supplement: CMI-168 |
| Placebo arm | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Cognitive function
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of Word Lists Subtest of the Weschler Memory Scale 3rd edition
Word Lists Subtest of the Weschler Memory Scale 3rd edition
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of Logical Memory Subtest of Weschler Memory Scale 3rd edition
Logical Memory Subtest of Weschler Memory Scale 3rd edition
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of Family Pictures Subtest of Weschler Memory Scale 3rd edition
Family Pictures Subtest of Weschler Memory Scale 3rd edition
Measured: From Day 0 to Day 28, Day 56 and Day 70
Secondary outcomes (15)
Change of serum ALT
serum ALT
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serum AST
serum AST
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serum BUN
serum BUN
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serum creatinin
serum creatinin
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serum T3
serum T3
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serum T4
serum T4
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serum TSH
serum TSH
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serum cortisol at 8 am
serum cortisol at 8 am
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serum fasting sugar
serum fasting sugar
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of Event related potential P300
Event related potential P300
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS)
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of State-Trait Anxiety Inventory (STAI)
State-Trait Anxiety Inventory (STAI)
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI)
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI)
Measured: From Day 0 to Day 28, Day 56 and Day 70
Change of serun brain-derived neurotrophic factor (BDNF)
serum brain-derived neurotrophic factor (BDNF)
Measured: From Day 0 to Day 28, Day 56 and Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start19 Jun 2018
- Primary completion28 Feb 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerebos Pacific Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Chaurjongh Hu, Cerebos Pacific Limited
- Investigators
- Chaurjong Hu, MD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612752
- Sponsor's protocol ID
- N201711060
- Status last verified
- Jul 2018
- First submitted
- 27 Jun 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu D, Yang CC, Chen KY, Lin YC, Wu PJ, Hsieh PH, Nakao Y, Ow MYL, Hsieh YC, Hu CJ. Hydrolyzed Chicken Extract (ProBeptigen(R)) on Cognitive Function in Healthy Middle-Aged People: A Randomized Double-Blind Trial. Nutrients. 2020 May 10;12(5):1362. doi: 10.3390/nu12051362.
PubMed 32397609
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03612752
- Acronym / sponsor ID
- N201711060
- Conditions
- Cognitive Change
- Keywords
- Chicken essence, cognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cerebos Pacific LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 2 Aug 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Dietary Supplement: CMI-168CMI-168 |
| Placebo arm | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| CMI-168Dietary supplement | Dietary supplement | Active arm |
| PlaceboPlacebo | Other | Placebo arm |
Primary outcome
Change of Cognitive function
Time frame: From Day 0 to Day 28, Day 56 and Day 70
Cambridge Neuropsychological Test Automated Battery (CANTAB)
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
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
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
15 secondary outcomes
Change of serum ALT
Time frame: 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
Change of serum BUN
Time frame: 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
Change of serum T3
Time frame: 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
Change of serum TSH
Time frame: 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
Change of serum fasting sugar
Time frame: 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
Change of Perceived Stress Scale (PSS)
Time frame: 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
Change of Beck Depression Inventory (BDI)
Time frame: 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
Change of serun brain-derived neurotrophic factor (BDNF)
Time frame: From Day 0 to Day 28, Day 56 and Day 70
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 32397609Wu D, Yang CC, Chen KY, Lin YC, Wu PJ, Hsieh PH, Nakao Y, Ow MYL, Hsieh YC, Hu CJ. Hydrolyzed Chicken Extract (ProBeptigen(R)) on Cognitive Function in Healthy Middle-Aged People: A Randomized Double-Blind Trial. Nutrients. 2020 May 10;12(5):1362. doi: 10.3390/nu12051362.
- 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.
Chaurjong Hu, MD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMI-168 in people with Cognitive Change, run by Cerebos Pacific Limited at 1 site in Taiwan.
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 16 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 2 Aug 2018. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Contact Dean Wu, PhD (886-9-70746912, tingyu02139@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Cognitive function (time frame: From Day 0 to Day 28, Day 56 and Day 70). The study lists 4 primary outcomes in all. 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 NCT03612752, which also lists 1 linked publication.
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 2 Aug 2018.