COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 5 of 5 for:    russell swerdlow

Therapeutic Diets in Alzheimer's Disease (TDAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03860792
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : November 1, 2019
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

Layout table for study information
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
Actual Study Start Date : October 29, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03860792

Layout table for location contacts
Contact: Jessica Keller, MS 913-588-5355
Contact: Matthew Taylor, PHD 913-588-5363

Layout table for location information
United States, Kansas
Clinical and Translational Science Unit Recruiting
Fairway, Kansas, United States, 66205
Sponsors and Collaborators
University of Kansas Medical Center
National Institute on Aging (NIA)
Layout table for additonal information
Responsible Party: Russell Swerdlow, MD, Professor, University of Kansas Medical Center Identifier: NCT03860792    
Other Study ID Numbers: STUDY00143457
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders