Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.

Cognitive Function 1, Social Clinical Trial

Official title:

Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396015
• Other study ID #: Pro00054165
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: May 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients.

Description:

The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients >49years with a clinical diagnosis of AD

• Mini Mental Status Examination (MMSE) score 10-29/30

• on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed)

• able to speak English

• patient or designate able to sign informed consent

• stable chronic medical conditions (Heart disease, thyroid disease)

• reliable caregiver

Exclusion Criteria:

• age <50 years

• medically unstable

• unable to swallow liquids

• diagnosis of diabetes mellitus

• residence in a nursing/long term care home

• allergy to coconut

• allergy to olive oil

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Function 1, Social
• Dementia

Intervention

Dietary Supplement:
• Bulletproof Brain Octane
Medium chain triglyceride oil (MCT)
• Placebo
Placebo (olive) oil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognition	Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function	15months
Primary	Cognition	Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition	15 months
Primary	cognition	Cognigram (Cogstate) 0-200. Higher score with higher cognitive function	15 months
Primary	Behavior	Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems	15 months
Primary	Function	Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function	15 months
Secondary	maximum tolerated daily dose (ml) of MCT oil	tolerability of MCT oil	11 months
Secondary	maximum tolerated daily dose (ml) of placebo (olive) oil	tolerability of placebo oil	4 months
Secondary	Serum cholesterol mmol/l	safety (% change from baseline)	15 months
Secondary	Serum Triglyceride mmol/l	safety (% change from baseline)	15 months
Secondary	Serum Low density lipoprotein (LDL) mmol/l	safety (% change from baseline)	15 months
Secondary	Dual Energy Absorptiometry (DXA) Body fat	safety (% change from baseline)	15 months
Secondary	Incidence of treatment-emergent Adverse events	safety. Mild, moderate or severe events.	15 months