Brain Energy for Amyloid Transformation in Alzheimer's Disease Study

NCT03472664 | Recruiting DMC

• 2 other identifiers: IRB000494741R01AG055122-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

Memory; Diet; ketogenic

Outcome Measures

Primary Outcomes (1)

• Cerebrospinal Fluid (CSF) Abeta42

  CSF Aβ42 is a a key AD biomarker that reflects pathological aggregation of amyloid in the brain.

  16 Weeks

Secondary Outcomes (3)

• CSF abeta42/ptau ratio

  16 Weeks

• Preclinical Alzheimer Cognitive Composite (PACC)

  16 Weeks

• Cerebral Blood Flow Measure with Arterial Spin Labeling (ASL) MRI

  16 Weeks

Study Arms (2)

Modified Mediterranean Ketogenic Diet

EXPERIMENTAL

The MMKD is a low carbohydrate/high fat diet aimed at inducing ketosis, as the experimental diet in the proposed study. Participants on the MMKD will keep their daily carbohydrate consumption below 20 grams per day throughout the 4 month intervention.The MMKD group will be supplied with extra virgin olive oil during their in person visits to use as a source of fat in their diet, and will be encouraged to eat plentiful fish, lean meats, and nutrient rich foods that meet the requirement of \<20 grams total carbohydrates per day. Participants will receive a daily multivitamin (Centrum Silver) over the course of the study and instructed to take 1 tablet each day while on the diet.

Other: low carbohydrate/high fat diet

American Heart Association Diet

EXPERIMENTAL

The American Heart Association Diet (AHAD), is a low fat/high carbohydrate diet (\<40 grams/day) will be used as the control diet. Participants on the AHAD will be encouraged to limit their amount of fat intake to \<40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber. Participants will receive the same daily multivitamin supplement (Centrum Silver) over the course of the study and instructed to take 1 tablet each day while on the diet.

Other: low fat/high carbohydrate diet

Interventions

low carbohydrate/high fat diet OTHER

Modified Mediterranean-Ketogenic Diet is a low carbohydrate/high fat diet.

Modified Mediterranean Ketogenic Diet

low fat/high carbohydrate diet OTHER

American Heart Association Diet is a low fat/high carbohydrate diet.

American Heart Association Diet

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of amnestic mild cognitive impairment
• An informant (study partner) able to provide collateral information on the participant
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Suzanne Craft, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Gagnon

CONTACT

(336) 713-8010; Karen.Gagnon@Advocatehealth.org

Lauren Latham

CONTACT

(336) 716-6317; lauren.latham@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is not possible for participants and the dietitian to be blinded to the study diet. Study personnel involved in performing cognitive testing or other outcome procedures or data analysis will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adults with amnestic mild cognitive impairment will be randomized on a 1:1 schedule to receive either a 4-month Modified Mediterranean Ketogenic Diet or American Heart Association Diet 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. Amyloid positron emission tomography (PET) will be conducted at baseline. Blood collection and cognitive assessment will be conducted at baseline and after 2 and 4 months of diet. Lumbar puncture (LP) and MRI will be conducted at baseline and following the intervention for all participants.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 21, 2018
• Study Start: July 16, 2018
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available one year after completion of the study and remain available indefinitely.
• Access Criteria: Consultation with the study team to verify purpose of data sharing request, and collaborative involvement of study team if appropriate.

Locations

US (1)