RECRUITING

Brain Energy for Amyloid Transformation in Alzheimer's Disease Study

Conditions

Alzheimer Disease Mild Cognitive Impairment Memory Diet ketogenic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study

Quick Facts

Study Start:2018-07-16

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03472664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Amy Hughes, AAS

CONTACT

336-716-8634

aehughes@wakehealth.edu

Principal Investigator

Suzanne Craft, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Suzanne Craft, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-16

Study Completion Date2026-04

Study Record Updates

Study Start Date2018-07-16

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Memory
Diet
ketogenic

Additional Relevant MeSH Terms

Alzheimer Disease
Mild Cognitive Impairment