The Brain Ketone Body Challenge Imaging Study

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Alzheimer Disease

Treatments: Dietary Supplement: Challenge A - low calorie Ensure®; Behavioral: Cognitive Testing - FCSRT; Behavioral: Story Recall; Behavioral: CogState One Card Learning; Behavioral: BVRT; Procedure: PET Scan; Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03204604

IRB00036958

Details and patient eligibility

About

The Brain Ketone Body Challenge Imaging Study will measure how the brain uses different fuels. To do this, radioactive compounds will be used during Positron Emission Tomography (PET) imaging.

These compounds, called [11C]Acetoacetate (AcAc) and [18F] Fludeoxyglucose (FDG), are similar to the sugars and fats the brain already uses for fuel. These compounds safely allow researchers to see how the brain uses sugars and fats during PET scans.

Full description

After consuming a chilled 4 ounce shake which contains various dietary fats, cognitive testing and dual-tracer Positron Emission Tomography scan will be completed. At Visit 1, each participant will be randomized to Challenge A (low calorie Ensure®) or Challenge B (Ensure® plus ketone esters). At Visit 2, each participant will undergo the remaining challenge (A or B) prior to the second imaging session. Each visit is designed to be identical to the other and only vary the dose of ketone esters. Randomization to either Challenge at Visit 1 will ensure that test/re-test learning effects are equally distributed between the challenge groups. This study consists of two visits that will take place over a two week period.

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Mild Cognitive Impairment (MCI)
• Stable medical condition
• Stable on medications for past 4 weeks
• Women must be post-menopausal

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 meeting any Diagnostic and Statistical Manual 4 (DSM-IV) criteria for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
• Diabetes that requires current use of diabetes medications
• Current use of cholesterol/lipid lowering medications
• History of epilepsy or seizure within past year
• Contraindications for imaging (e.g. claustrophobia or high prior radiation exposure)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Challenge A

Experimental group

Description:

Challenge A includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with low calorie Ensure® shake containing no ketone esters. Dietary Supplement: Challenge A - low calorie Ensure®

Treatment:

Behavioral: Cognitive Testing - FCSRT

Behavioral: CogState One Card Learning

Behavioral: Story Recall

Behavioral: BVRT

Procedure: PET Scan

Dietary Supplement: Challenge A - low calorie Ensure®

Challenge B

Experimental group

Description:

Challenge B includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with an Ensure® shake containing ketone esters. Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)

Treatment:

Behavioral: Cognitive Testing - FCSRT

Behavioral: CogState One Card Learning

Behavioral: Story Recall

Behavioral: BVRT

Procedure: PET Scan

Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)