Alzheimer Disease
Conditions
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.
Interventions
BEHAVIORALKetogenic Diet
Three-month 1:1 ketogenic diet intervention (approximately 70% fat, \<10% carbohydrate, and 20% protein).
BEHAVIORALTherapeutic 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.
Sponsors
University of Kansas Medical Center
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcomes assessors are masked from participant group assignment.
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Performance on the Stroop Color Test | 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. |
| Change in Cognitive Performance on the Stroop Color-Word Test | 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. |
| Change in Cognitive Performance on the Mini-Mental State Exam (MMSE) | 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. |
| Change in Cognitive Performance on the Logical Memory Test 1 (LMT1) | 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. |
| Change in Cognitive Performance on the Logical Memory Test 2 (LMT2) | 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. |
| Change in Clinical Dementia Rating (CDR) | 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. |
| Change in Frontal Lobe Concentration of N-Acetylaspartate (NAA) | Baseline, 12 Weeks | Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner. |
| Change in Frontal Lobe Concentration of Glutamate Plus Glutamine (Glx) | Baseline, 12 weeks | Concentration of cerebral glutamate plus glutamine (Glx) is measured using magnetic resonance spectroscopy in a 3T clinical scanner. |
| Change in Cognitive Performance on the Stroop Word Test | 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. |
| Change in Blood Platelet COX/CS Vmax | 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 |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.2 Years STANDARD_DEVIATION 6.56 |
| BMI | 27.0 kg/m2 STANDARD_DEVIATION 5.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 17 / 42 | 9 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
None listed