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Therapeutic Diets in Alzheimer's Disease (TDAD)

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ClinicalTrials.gov Identifier: NCT03860792
Recruitment Status : Not yet recruiting
First Posted : March 4, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Russell Swerdlow, MD, 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Ketogenic Diet Behavioral: Therapeutic Lifestyles Changes Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: All outcomes assessors are masked from participant group assignment.
Primary Purpose: Treatment
Official Title: Therapeutic Diets in Alzheimer's Disease
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketogenic Diet
Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, <10% carbohydrate, and 20% protein as energy). The diet will encourage ≥4 servings of non-starchy vegetables and 1/2 cup of berries daily. Participants will be provided an emulsified medium chain triglyceride supplement with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet.
Behavioral: Ketogenic Diet
Three-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).

Active Comparator: Therapeutic Lifestyles Changes Diet
Study partners will be instructed to assist participants in adherence to the Therapeutic Lifestyles Changes diet. The diet consists of 20-35% fat, 50-60% carbohydrate, and ~15% protein as energy. Fat intake will comprise <7% saturated fat, ≤20% monounsaturated fat, and ≤10% polyunsaturated fat as total energy. Cholesterol consumption will be ≤200mg per day. Participants are encouraged to eat ≥2 servings of fruit and ≥5 servings of vegetables per day.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11) [ Time Frame: 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.

  2. Change in cognitive performance on the Mini-Mental State Exam (MMSE) [ Time Frame: 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.

  3. Change in cognitive performance on the Logical Memory Test (LMT) [ Time Frame: 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.

  4. Change in cognitive performance by Stroop test [ Time Frame: Baseline, 12 Weeks ]
    Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.

  5. Change in Clinical Dementia Rating (CDR) [ Time Frame: 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 :
  1. Change in cerebral concentration of N-Acetylaspartate (NAA) [ Time Frame: Baseline, 12 Weeks ]
    Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.

  2. Change in blood platelet mitochondrial function [ Time Frame: 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.

  3. Change in self-reported symptoms by study partner [ Time Frame: Baseline, 6 Weeks, 12 Weeks ]
    Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.


Other Outcome Measures:
  1. Change in blood ketone levels induced by ketogenic diet [ Time Frame: Baseline, 6 Weeks, 12 Weeks ]
    We will measure serum beta-hydroxybutyrate levels.

  2. Proportion of days positive for urinary ketone production [ Time Frame: Daily for 90 days (the length of the diet intervention) ]
    Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).

  3. Dietary intake characterization prior to and after ketogenic diet initiation [ Time Frame: Baseline, 6 Weeks, 12 Weeks ]
    Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Russell Swerdlow, MD, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03860792     History of Changes
Other Study ID Numbers: STUDY00143457
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders