Alzheimer DiseaseTDADNCT03860792
Therapeutic Diets in Alzheimer's Disease
A study testing Ketogenic Diet and Therapeutic Lifestyles Changes Diet in people with Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Ketogenic Diet and Therapeutic Lifestyles Changes Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 20 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Science Unit
Fairway, Kansas, 66205
About this study
By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- Ketogenic Diet, Therapeutic Lifestyles Changes Diet
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietBehavioural
Three-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).
Therapeutic Lifestyles Changes DietBehavioural
Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | 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. Receives: Behavioral: Ketogenic Diet |
| Therapeutic Lifestyles Changes Diet | Active comparator | 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. Receives: Behavioral: Therapeutic Lifestyles Changes Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 Weeks
Secondary outcomes (10)
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 range of 0 to 30 points where higher scores indicate better cognitive performance.
Measured: Baseline, 12 Weeks
Change in Cognitive Performance on the Logical Memory Test 1 (LMT1)
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.
Measured: Baseline, 12 Weeks
Change in Cognitive Performance on the Logical Memory Test 2 (LMT2)
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.
Measured: Baseline, 12 weeks
Change in Cognitive Performance on the Stroop Word Test
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.
Measured: Baseline, 12 Weeks
Change in Cognitive Performance on the Stroop Color Test
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.
Measured: Baseline, 12 weeks
Change in Cognitive Performance on the Stroop Color-Word Test
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 Weeks
Change in Frontal Lobe Concentration of N-Acetylaspartate (NAA)
Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.
Measured: Baseline, 12 Weeks
Change in Frontal Lobe Concentration of Glutamate Plus Glutamine (Glx)
Concentration of cerebral glutamate plus glutamine (Glx) is measured using magnetic resonance spectroscopy in a 3T clinical scanner.
Measured: Baseline, 12 weeks
Change in Blood Platelet COX/CS Vmax
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
Measured: Baseline, 6 Weeks, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start15 Oct 2019
- Primary completion23 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Russell Swerdlow, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860792
- Sponsor's protocol ID
- STUDY00143457
- Acronym
- TDAD
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2019
- Last updated
- 8 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No