Brain Energy for Amyloid Transformation in Alzheimer's Disease Study (NCT03472664) | Clinical Trial Compass
CompletedNot Applicable
Brain Energy for Amyloid Transformation in Alzheimer's Disease Study
United States84 participantsStarted 2018-07-16
Plain-language 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.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether a dietary or metabolic intervention could change amyloid levels in spinal fluid — since it's now completed, has the data been published, and what did it actually find about Abeta42 levels in people with mild cognitive impairment or early Alzheimer's?
2The trial measured amyloid in cerebrospinal fluid, which requires a spinal tap — how would you weigh the discomfort and risks of that procedure against what we might learn from participating in a study like this?
3Since this study is listed as 'Phase NA,' meaning it wasn't a standard drug trial, can you help me understand what kind of intervention was being tested and whether its findings would be relevant to my specific diagnosis?
4If the results of this completed trial showed a meaningful change in amyloid levels, does that translate into something I should consider acting on now, or is changing amyloid in spinal fluid still more of a research marker than a proven clinical benefit?
5Given that this trial is already completed and no longer enrolling, are there similar ongoing studies on brain energy metabolism and Alzheimer's that my care team thinks would be worth looking into as a next step?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.