CMI-168 on Cognitive Function in Healthy Middle-aged Men and Women
NCT03612752 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2018-08-02
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.
Conditions
- Cognitive Change
Interventions
- DIETARY_SUPPLEMENT
-
CMI-168
Dietary supplement
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
Cerebos Pacific Limited
lead INDUSTRY
Principal Investigators
-
Chaurjong Hu, MD · Taipei Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-06-19
- Primary Completion
- 2019-02-28
- Completion
- 2019-03-31
Countries
- Taiwan
Study Locations
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