Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03612752
Status:
UNKNOWN
Last Update Posted:
2018-08-02
First Post:
2018-06-27
Brief Title:
CMI-168 on Cognitive Function in Healthy Middle-aged Men and Women
Sponsor:
Cerebos Pacific Limited
Organization:
Cerebos Pacific Limited
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 ratio to two treatment arms
CMI-168 2 tablet once daily 56 days
Placebo 2 tablets once daily 56 days
Following randomisationthe 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
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 11 ratio to two treatment arms
CMI-168 2 tablet once daily 56 days
Placebo 2 tablets once daily 56 days
Following randomisationthe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None