Therapeutic Diets in Alzheimer's Disease

Alzheimer Disease Clinical Trial

— TDAD  

Official title:

Therapeutic Diets in Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03860792
• Other study ID #: STUDY00143457
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: University of Kansas Medical Center
• Contact: Jessica Keller, MS
• Phone: 913-588-5355
• Email: kkali17[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• Ketogenic Diet
Three-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).
• Therapeutic Lifestyles Changes Diet
Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.

Locations

Country	Name	City	State
United States	Clinical and Translational Science Unit	Fairway	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood ketone levels induced by ketogenic diet	We will measure serum beta-hydroxybutyrate levels.	Baseline, 6 Weeks, 12 Weeks
Other	Proportion of days positive for urinary ketone production	Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).	Daily for 90 days (the length of the diet intervention)
Other	Dietary intake characterization prior to and after ketogenic diet initiation	Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.	Baseline, 6 Weeks, 12 Weeks
Primary	Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)	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.	Baseline, 12 Weeks
Primary	Change in cognitive performance on the Mini-Mental State Exam (MMSE)	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.	Baseline, 12 Weeks
Primary	Change in cognitive performance on the Logical Memory Test (LMT)	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.	Baseline, 12 Weeks
Primary	Change in cognitive performance by Stroop test	Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.	Baseline, 12 Weeks
Primary	Change in Clinical Dementia Rating (CDR)	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.	Baseline, 12 Weeks
Secondary	Change in cerebral concentration of N-Acetylaspartate (NAA)	Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.	Baseline, 12 Weeks
Secondary	Change in blood platelet mitochondrial function	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.	Baseline, 6 Weeks, 12 Weeks
Secondary	Change in self-reported symptoms by study partner	Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.	Baseline, 6 Weeks, 12 Weeks