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Keto diet tested as brain booster in early Alzheimer's trial

NCT ID NCT03472664

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

The BEAT-AD study is testing whether a low-carb, high-fat ketogenic diet can improve thinking and memory in 120 adults with mild cognitive impairment, a precursor to Alzheimer's. Participants are randomly assigned to either a ketogenic diet or a low-fat diet for 16 weeks, with follow-up 8 weeks later. Researchers will measure changes in brain blood flow, spinal fluid proteins, and cognitive test scores to see if diet can alter Alzheimer's-related brain changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Modified Mediterranean-Ketogenic Diet (low-carb/high-fat) or American Heart Association Diet (low-fat/high-carb)
What this could lead to
If successful, this could show that a specific diet helps slow cognitive decline in people with early memory problems, pointing toward a simple lifestyle approach for Alzheimer's prevention.
What could go wrong
This is a small, early-stage study (120 people) that only lasts 16 weeks on the diet. It measures biomarkers, not long-term disease progression, so results may not translate to real-world benefits. Diet adherence can be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

84 people

The number who actually took part.

Started

Jul 2018

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Mild cognitive impairment

Contacts and locations

Locations

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.