Skip to main content
OpenTrials
Completed

NCT Number: NCT04396015

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Function 1, Social

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bulletproof Brain Octane

Dietary Supplement

Medium chain triglyceride oil (MCT)

Placebo

Dietary Supplement

Placebo (olive) oil

Primary outcomes

  1. cognition

    Time frame: 15months

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

  2. Cognition

    Time frame: 15 months

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

  3. cognition

    Time frame: 15 months

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

  4. Behavior

    Time frame: 15 months

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

  5. Function

    Time frame: 15 months

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

Secondary outcomes

  1. maximum tolerated daily dose (ml) of MCT oil

    Time frame: 11 months

    tolerability of MCT oil

  2. maximum tolerated daily dose (ml) of placebo (olive) oil

    Time frame: 4 months

    tolerability of placebo oil

  3. Serum cholesterol mmol/l

    Time frame: 15 months

    safety (% change from baseline)

  4. Serum Triglyceride mmol/l

    Time frame: 15 months

    safety (% change from baseline)

  5. Serum Low density lipoprotein (LDL) mmol/l

    Time frame: 15 months

    safety (% change from baseline)

  6. Dual Energy Absorptiometry (DXA) Body fat

    Time frame: 15 months

    safety (% change from baseline)

  7. Incidence of treatment-emergent Adverse events

    Time frame: 15 months

    safety. Mild, moderate or severe events.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 20, 2020
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.