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

NCT04396015 | Completed DMC

• 1 other identifier: Pro00054165
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cognitive Function 1, Social

Outcome Measures

Primary Outcomes (5)

• cognition

  Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function

  15months

• Cognition

  Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition

  15 months

• cognition

  Cognigram (Cogstate) 0-200. Higher score with higher cognitive function

  15 months

• Behavior

  Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems

  15 months

• Function

  Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function

  15 months

Secondary Outcomes (7)

• maximum tolerated daily dose (ml) of MCT oil

  11 months

• maximum tolerated daily dose (ml) of placebo (olive) oil

  4 months

• Serum cholesterol mmol/l

  15 months

• Serum Triglyceride mmol/l

  15 months

• Serum Low density lipoprotein (LDL) mmol/l

  15 months

Study Arms (2)

medium chain triglyceride (MCT) vs placebo

PLACEBO COMPARATOR

MCT or placebo (olive oil) for 4 months. Crossover at 4 months

Dietary Supplement: Bulletproof Brain Octane; Dietary Supplement: Placebo

open label extension

OTHER

6 months of MCT oil.

Dietary Supplement: Bulletproof Brain Octane

Interventions

Bulletproof Brain Octane DIETARY_SUPPLEMENT

Medium chain triglyceride oil (MCT)

medium chain triglyceride (MCT) vs placebo; open label extension

Placebo DIETARY_SUPPLEMENT

Placebo (olive) oil

medium chain triglyceride (MCT) vs placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind placebo controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: randomized, placebo control cross-over study, with an open label extension

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: May 20, 2020
• Study Start: March 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share