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Completed

NCT Number: NCT03860792

Therapeutic Diets in Alzheimer's Disease

By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical and Translational Science Unit

Fairway, Kansas, 66205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketogenic diet

Behavioral

Three-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).

Therapeutic Lifestyles Changes Diet

Behavioral

Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.

Primary outcomes

  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.

Secondary outcomes

  1. 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 range of 0 to 30 points where higher scores indicate better cognitive performance.

  2. Change in Cognitive Performance on the Logical Memory Test 1 (LMT1)

    Time frame: Baseline, 12 Weeks

    The Logical Memory, subtest of the WMS-R is a standardized assessment of narrative episodic memory, with a scaled score range of 1 to 19, where higher scores indicate better performance. A short story is orally presented, and the examinee is asked to recall the story immediately.

  3. Change in Cognitive Performance on the Logical Memory Test 2 (LMT2)

    Time frame: Baseline, 12 weeks

    The amount of information retained after a delay following the initial introduction of the material to be learned. The result is a scaled score range of 1 to 19, where higher scores indicate better performance.

  4. Change in Cognitive Performance on the Stroop Word Test

    Time frame: Baseline, 12 Weeks

    Number of items named per the rules of this test as assessed by a psychometrician. It determines a raw score value of 0 to 100, with higher values indicating better performance.

  5. Change in Cognitive Performance on the Stroop Color Test

    Time frame: Baseline, 12 weeks

    Number of items generated per the rules of the test as assessed by a psychometrician. It determines a raw score value of 0 to 100, with higher values indicating better performance.

  6. Change in Cognitive Performance on the Stroop Color-Word Test

    Time frame: Baseline, 12 weeks

    Number of items generated per the rules of the test as assessed by a psychometrician. It determines a raw score value of 0 to 100, with higher values indicating better performance.

  7. 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.

  8. Change in Frontal Lobe 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.

  9. Change in Frontal Lobe Concentration of Glutamate Plus Glutamine (Glx)

    Time frame: Baseline, 12 weeks

    Concentration of cerebral glutamate plus glutamine (Glx) is measured using magnetic resonance spectroscopy in a 3T clinical scanner.

  10. Change in Blood Platelet COX/CS Vmax

    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, referenced to the citrate synthase activity

Other outcomes

  1. Change in Blood Ketone Levels Induced by Ketogenic Diet

    Time frame: Baseline, 12 Weeks

    We will measure serum beta-hydroxybutyrate levels as determined by Quest Diagnostics.

  2. Proportion of Reported Days Positive for Urinary Ketone Production

    Time frame: Reported days for all the days in the intervention, from the Baseline Visit to the 12-Week Visit

    Participant measured urine ketone status using Ketostix (Bayer, Germany) on days collected and reported.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: TDAD

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2019
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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