Therapeutic Diets in Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Registration Number
- NCT03860792
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Diagnosis of AD by current McKhann et al. criteria
- CDR global score of 0.5 or 1
- Agreed cooperation from an appropriate study partner
- Speaks English as primary language
- Age 50 to 90
- No medication changes within the past 30 days
- Resides in a nursing home or dementia special care unit, or cannot control diet
- A potentially confounding serious medical risk including insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
- Participating in another clinical trial or using an investigational drug or therapy within 30 days of the Screening Visit
- A history of renal stones
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in cognitive performance on the Mini-Mental State Exam (MMSE) Baseline, 12 Weeks Global cognitive performance will be assessed by a psychometrician using the Mini-Mental State Exam (MMSE). The MMSE is a brief cognitive questionnaire with a maximum score of 30 points where higher scores indicate better cognitive performance.
Change in cognitive performance on the Logical Memory Test (LMT) Baseline, 12 Weeks The Logical Memory, subtest of the WMS-R is a standardized assessment of narrative episodic memory. A short story is orally presented, and the examinee is asked to recall the story immediately.
Change in cognitive performance by Stroop test Baseline, 12 Weeks Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.
Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11) Baseline, 12 Weeks Cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11). The ADAS-Cog is an Alzheimer's disease specific, multi-domain cognitive assessment scored from 0-70 points with higher scores indicating poorer cognitive performance.
Change in Clinical Dementia Rating (CDR) Baseline, 12 Weeks The Clinical Dementia Rating is a 5-point scale (CDR 0, 0.5, 1, 2, and 3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. CDR 0 indicates no dementia and higher values indicate more severe dementia. The scores of all six domains are averaged to form a global CDR score. Change in score from baseline to 3 months will be assessed.
- Secondary Outcome Measures
Name Time Method Change in self-reported symptoms by study partner Baseline, 6 Weeks, 12 Weeks Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.
Change in cerebral concentration of N-Acetylaspartate (NAA) Baseline, 12 Weeks Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.
Change in blood platelet mitochondrial function Baseline, 6 Weeks, 12 Weeks Cytochrome c oxidase activity of blood platelets will be determined as a pseudo first order-rate constant (sec-1/mg protein) by measuring the oxidation of reduced cytochrome c at 550 nm.
Trial Locations
- Locations (1)
Clinical and Translational Science Unit
🇺🇸Fairway, Kansas, United States
Clinical and Translational Science Unit🇺🇸Fairway, Kansas, United States