Age-associated Memory Impairment Clinical Trial
— PHAEO-FOUROfficial title:
A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
Verified date | November 2023 |
Source | Microphyt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline. In a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks. Cognitive function battery will be realized after 4 and 12 weeks of supplementation.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 55 Years |
Eligibility | Inclusion Criteria: - Be able to give written informed consent and to consume the investigational product daily for the duration of the study. - Healthy males and females aged = 55 and = 75 years old. - Body-mass index between 18.5 and 35.0 kg/m2 - Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance). - Have age-associated memory impairment (AAMI) based on the following National Institute of Mental Health criteria, specified as scoring: 1. Absence of dementia as determined by a score of >24 on the Mini Mental State Examination (MMSE). 2. =29 or =9 on the VPA I and II portions of the Wechsler Memory Scale IV, respectively 3. A score on the MAC-Q of =25. - Is in general good health, as determined by the investigator - Ability to comply and understand the cognitive function practice tests - Willing to maintain their habitual diet and exercise routines. - Willing to maintain consistent sleep duration the evening before study visits. Exclusion Criteria: - Use of medications or supplements known to alter cognitive function within past 2 weeks - Abnormal clinical laboratory test that may affect study outcome. - History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurological disorders (including sleep disorders, head injuries, Alzheimer's disease, Parkinson's disease, stroke, inflammatory brain disease - History or presence of cancer, except nonmelanoma skin cancer - Uncontrolled hypertension/diabetes - History of depression within past 24 months or use of psychotropic medications within 1 month of screening - Planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study. - History within previous 12 months of alcohol or substance abuse. - History of heavy smoking (>1 pack/day) within past 3 months |
Country | Name | City | State |
---|---|---|---|
United States | Exercise & Sport Nutrition Lab | College Station | Texas |
Lead Sponsor | Collaborator |
---|---|
Microphyt | Texas A&M University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in spatial Working Memory | Mean Span Score in Corsi Blocks module of the COMPASS | From week 0 to week 12 | |
Secondary | Change in spatial working memory | Mean Span Score in Corsi Blocks module of the COMPASS | From week 0 to week 4 | |
Secondary | Change in attention and vigilance | Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS | From week 0 to week 12 | |
Secondary | Change in attention and vigilance | Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS | From week 0 to week 4 | |
Secondary | Change in executive function | Mean reaction time and accuracy in Stroop task module of the COMPASS | From week 0 to week 12 | |
Secondary | Change in executive function | Mean reaction time and accuracy in Stroop task module of the COMPASS | From week 0 to week 4 | |
Secondary | Change in episodic memory | Mean reaction time and accuracy in Stroop task module of the COMPASS | From week 0 to week 12 | |
Secondary | Change in episodic memory | Mean reaction time and accuracy in Stroop task module of the COMPASS | From week 0 to week 4 | |
Secondary | Change in perceptual and cognitive skills | Mean reaction time and accuracy in Neurotracker light reaction test | From week 0 to week 4 | |
Secondary | Change in perceptual and cognitive skills | Mean reaction time and accuracy in Neurotracker light reaction test | From week 0 to week 12 | |
Secondary | Stress level | Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress) | From week 0 to week 4 | |
Secondary | Stress level | Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress) | From week 0 to week 12 | |
Secondary | Sleep quality | Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality) | From week 0 to week 12 | |
Secondary | Sleep quality | Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality) | From week 0 to week 4 | |
Secondary | Mood state | Change Bond-Lader Mood rating scale from 0 to 10 (low mood state) | From week 0 to week 4 | |
Secondary | Mood state | Change Bond-Lader Mood rating scale from 0 to 10 (low mood state) | From week 0 to week 12 | |
Secondary | Inflammation IL-6 | Change Interleukin-6 level (pg/ml) | from week 0 to week 12 | |
Secondary | Inflammation IL-6 | Change Interleukin-6 level (pg/ml) | from week 0 to week 4 |
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