Brain Energy for Amyloid Transformation in Alzheimer's Disease Study
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Cognitive Studies, Cognitive Studies |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 55 - 85 |
| Updated: | 8/3/2018 |
| Start Date: | July 16, 2018 |
| End Date: | April 2023 |
| Contact: | Ashley Sanderlin, PhD |
| Email: | asanderl@wakehealth.edu |
| Phone: | 336-713-8817 |
Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study
The Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will
compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with
mild cognitive impairment. The data collected will help determine whether diet interventions
induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and
hormones in body fluids.
The study will include volunteers who have mild cognitive impairment, who will be randomly
assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks,
with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and
phone sessions will occur at baseline and throughout the 24-week study.
Group 2 will include volunteers who have mild cognitive impairment. This group will complete
a 16-week low-fat diet study, with follow-up assessment 8 weeks after diet final completion.
Study measures, clinic visits and phone sessions will occur throughout the 24-week study.
Participant will follow either a low-carbohydrate or low-fat diet that will be individually
planned with help from a study dietitian. After completing the study diet for 16 weeks,
participants will resume their normal diet. The final visits will occur at week 24 (8 weeks
after the completing the diet). At the end of the 24-week study, participants will be given
the opportunity to meet with the study dietitian for education and assistance with planning a
healthy diet.
compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with
mild cognitive impairment. The data collected will help determine whether diet interventions
induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and
hormones in body fluids.
The study will include volunteers who have mild cognitive impairment, who will be randomly
assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks,
with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and
phone sessions will occur at baseline and throughout the 24-week study.
Group 2 will include volunteers who have mild cognitive impairment. This group will complete
a 16-week low-fat diet study, with follow-up assessment 8 weeks after diet final completion.
Study measures, clinic visits and phone sessions will occur throughout the 24-week study.
Participant will follow either a low-carbohydrate or low-fat diet that will be individually
planned with help from a study dietitian. After completing the study diet for 16 weeks,
participants will resume their normal diet. The final visits will occur at week 24 (8 weeks
after the completing the diet). At the end of the 24-week study, participants will be given
the opportunity to meet with the study dietitian for education and assistance with planning a
healthy diet.
This study will examine the effects of a 4-month Modified Mediterranean-Ketogenic Diet
compared with an American Heart Association Diet (AHAD - a regimen that has been shown to
reduce the risk for cardiovascular disease). We will investigate diet effects on AD
biomarkers, on cognition, and on neuroimaging measures of blood flow. Our study will extend
previous findings in several important ways by: 1) using a Modified Mediterranean-Ketogenic
Diet rather than a traditional Ketogenic Diet, which has the potential for greater long-term
compliance and health benefits; 2) increasing the sample size and duration of the diet
intervention; 3) examining potential mechanisms of diet effects that may result in new
biomarkers and therapeutic targets; and 4) examining key treatment response variables such as
Apolipoprotein E (ApoE) genotype, amyloid positivity and metabolic status that could inform
precision medicine approaches to dietary prescription.
Adults with amnestic mild cognitive impairment (MCI) will be randomized on a 1:1 schedule to
receive either a 4-month Modified Mediterranean-Ketogenic Diet (MMKD) or American Heart
Association Diet (AHAD) intervention. Diet interventions will be equicaloric with
participants' normal diets. Personalized nutritional guidance and menus will be provided, and
compliance will be assessed by a registered dietitian. The principal investigator will be
responsible for the overall monitoring of the data and safety of study participants, with
assistance by members of the study staff, and the Data and Safety Monitoring Board (DSMB),
which will be responsible for monitoring the safety of research participants.
compared with an American Heart Association Diet (AHAD - a regimen that has been shown to
reduce the risk for cardiovascular disease). We will investigate diet effects on AD
biomarkers, on cognition, and on neuroimaging measures of blood flow. Our study will extend
previous findings in several important ways by: 1) using a Modified Mediterranean-Ketogenic
Diet rather than a traditional Ketogenic Diet, which has the potential for greater long-term
compliance and health benefits; 2) increasing the sample size and duration of the diet
intervention; 3) examining potential mechanisms of diet effects that may result in new
biomarkers and therapeutic targets; and 4) examining key treatment response variables such as
Apolipoprotein E (ApoE) genotype, amyloid positivity and metabolic status that could inform
precision medicine approaches to dietary prescription.
Adults with amnestic mild cognitive impairment (MCI) will be randomized on a 1:1 schedule to
receive either a 4-month Modified Mediterranean-Ketogenic Diet (MMKD) or American Heart
Association Diet (AHAD) intervention. Diet interventions will be equicaloric with
participants' normal diets. Personalized nutritional guidance and menus will be provided, and
compliance will be assessed by a registered dietitian. The principal investigator will be
responsible for the overall monitoring of the data and safety of study participants, with
assistance by members of the study staff, and the Data and Safety Monitoring Board (DSMB),
which will be responsible for monitoring the safety of research participants.
Inclusion Criteria:
- Diagnosis of amnestic mild cognitive impairment
- An informant (study partner) able to accompany the participant to at least 3 visits,
including at least two diet education visits
- Stable medical condition (generally 3 months prior to screening visit) at the
discretion of study physician
- Stable on medications (generally 4 weeks prior to screening visit) at the discretion
of study physician
- Able to complete baseline assessments
Exclusion Criteria:
- Diagnosis of neurodegenerative illness (except for MCI);
- History of a clinically significant stroke
- Current evidence or history in past year of focal brain lesion, head injury with loss
of consciousness or DSM-IV criteria for any major psychiatric disorder including
psychosis, major depression, bipolar disorder, alcohol or substance abuse
- Sensory impairment (i.e.: visual or auditory) that would preclude the participant from
participating in the protocol
- Diabetes that requires current use of diabetes medications
- Clinically significant elevations in liver function tests
- Active neoplastic disease (stable prostate cancer and non-melanoma skin cancer is
permissible)
- History of epilepsy or seizure within past year
- Contraindications for MRI (claustrophobia, craniofacial metal implants, pacemakers)
- Significant medical illness or organ failure, such as uncontrolled hypertension or
cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or
kidney disease
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