Supplementing Neuro-Energy to Aid Cognition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-01

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

It is projected that by 2030, one in every five Americans will be of retirement age, and this demographic shift is expected to result in more people suffering from dementia. A key feature of the brain is its need for a constant supply of glucose and oxygen to meet the high energy costs of mental activity. This study aims to develop clinically practical, noninvasive imaging methods based on combined positron emission tomography and magnetic resonance imaging to assess brain energy in order to better understand how this critical component of brain health is impacted by aging.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Proof of Mechanism of a New Ketogenic Supplement Using Dual Tracer PET (Positron Emission Tomography)

NCT02551419

Mild Cognitive Impairment

COMPLETED NA

The Brain Ketone Body Challenge Imaging Study

NCT03204604

Alzheimer Disease

WITHDRAWN NA

PET Scan of Brain Metabolism in Relation to Age and Disease

NCT00001972

Alzheimer's Disease Brain Neoplasm Niemann Pick Disease

COMPLETED

Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Risk Factors for Alzheimer's Disease

NCT03130036

Mild Cognitive Impairment

COMPLETED NA

Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down Syndrome and Dementia

NCT00966017

Down Syndrome Alzheimer's Disease

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There are now close to six million people in the Unites States living with dementia and this number is only expected to grow as the population continues to age. The current lack of effective treatments for Alzheimer's disease (AD) speaks to the need to better understand the multiple factors that contribute to this complex disease. There is growing evidence that age-related metabolic dysfunction in the brain plays a role in the disease's etiology. This concept has led to treatments aimed at improving brain energy production. Notably, ketogenic dietary supplements have been shown to increase brain ketone metabolism and improve cognitive performance in AD patients. However, the overall benefits to brain metabolism in the AD brain are unknown given the complexity of imaging both oxygen and glucose metabolism in a single session by positron emission tomography (PET). Taking advantage of hybrid PET/MR imaging, this study will combine PET and MRI methods to investigate the effects of a ketogenic supplement on brain oxygen and glucose metabolism in AD patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease and Related Dementias (ADRD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each patient receives a placebo and the active treatment on separate occasions undergoing the same imaging protocol.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will not know if they have consumed the keytone ester supplement drink or a placebo drink.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alzheimer's Disease Patients - Treatment

Patients within the Alzheimer's continuum will be selected based on the National Institute of Aging - Alzheimer's Association Diagnostic Framework and be either classified as having mild cognitive impairment or mild-to-moderate dementia. Participants will undergo two PET/MR sessions in which CMRGlu and CMRO2 will be imaged simultaneously by PET and qBOLD MRI. For validation, CMRO2 will also be imaged by PMROx prior to FDG injection. The study will follow a crossover design in which participants will receive ketogenic supplement prior to imaging.

Group Type ACTIVE_COMPARATOR

Ketogenic Supplement

Intervention Type DIETARY_SUPPLEMENT

Commercially available ketone ester drink

Alzheimer's Disease Patients - Placebo

Patients within the Alzheimer's continuum will be selected based on the National Institute of Aging - Alzheimer's Association Diagnostic Framework and be either classified as having mild cognitive impairment or mild-to-moderate dementia. Participants will undergo two PET/MR sessions in which CMRGlu and CMRO2 will be imaged simultaneously by PET and qBOLD MRI. For validation, CMRO2 will also be imaged by PMROx prior to FDG injection. The study will follow a crossover design in which participants will receive a placebo drink prior to imaging.

Group Type PLACEBO_COMPARATOR

Placebo Drink

Intervention Type OTHER

Placebo drink containing sunflower oil.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketogenic Supplement

Commercially available ketone ester drink

Intervention Type DIETARY_SUPPLEMENT

Placebo Drink

Placebo drink containing sunflower oil.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ketone-IQTM

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria - Healthy Participants: Males and females, Age 21 - 80 years, BMI of 18.5-30

Inclusion Criteria - Alzheimer's Disease Participants: Positive amyloid and tau biomarkers (as noted by PET imaging, cerebrospinal fluid or blood), Mild cognitive impairment or mild-to-moderate dementia, BMI of 18.5-30

Exclusion Criteria: Contraindications to MRI (claustrophobia, metal implants, pacemakers, etc.), Pregnant or breastfeeding women, Neurological disease (healthy participants only), Mental illness, Overt cardio- or neurovascular disease, Recent participation in any procedure(s) involving radioactive agents

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes