Condition category
Mental and Behavioural Disorders
Date applied
10/10/2013
Date assigned
05/11/2013
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aims of this study are to examine the safety and tolerability of a ketone monoester in dementia, and to gather initial data on its effect on cognitive (thought) and motor (movement) function. The ketone monoester is rapidly broken down into a form which neurones (nerve cells) can use instead of glucose.

Who can participate?
Patients with moderate or severe dementia are eligible if they have a caregiver who can give good information about their behaviour and functioning.

What does the study involve?
All 24 patients will take the ketone monoester three times daily for a week. The first and last dose will be taken in the clinic and after cognitive and motor testing.

What are the possible benefits and risks of participating?
There are unlikely to be direct benefits from participation in a short one-week study.
Young healthy volunteers who took the product at substantially higher doses and in different formulations than in this study experienced some side effects like nausea, bloating and dizziness.

Where is the study run from?
The study is running in Oxford and Northamptonshire (UK).

When is the study starting and how long is it expected to run for?
It is anticipated that the study will start in October 2013 and is expected to run until March 2014.

Who is funding the study?
University of Oxford, UK.

Who is the main contact?
Dr Rupert McShane
rupert.mcshane@oxfordhealth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rupert McShane

ORCID ID

Contact details

Warneford Hospital
Oxford
OX3 7JX
United Kingdom
-
rupert.mcshane@oxfordhealth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v1.1

Study information

Scientific title

Exploratory study of a ketogenic dietary supplement in dementia: a phase 1 pharmacokinetic and safety study

Acronym

KETOCOG-01

Study hypothesis

That a ketone monoester drink will be tolerated; converted to safe levels of ketones; and not cause adverse events when taken three times daily for a week.

Ethics approval

South West Wales Research Ethics Committee, 20/09/2013, ref: 13/WA/0267

Study design

Two centres phase 1 before-and-after case series

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dementia

Intervention

All participants will receive oral 25g D-β-hydroxybutyrate-R 1,3 butanediol three times daily for a week. There are no control groups.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ketone monoesters

Primary outcome measures

1. Ketone levels
2. Adverse events
3. Tolerability
4. Change in Severe Impairment Battery (SIB) at 8 days
5. Clinician Interview Based Impression of Change (CIBIC+)

Measured at baseline and one week only

Secondary outcome measures

1. Change in Alzheimer’s Disease Cooperative Study - Activities of Daily Living scale at 8 days
2. Change in Neuropsychiatric Inventory – carer distress version (NPI) at 8 days
3. Change in Quality of Life measures at 8 days
4. Acute changes in cognitive tests: digit span, Executive Clock Drawing Task (CLOX), semantic fluency
5. Acute changes in fine and gross motor function: Peg Board, Get Up and Go

Measured at baseline and one week only

Overall trial start date

21/10/2013

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female, age over 70 years old
2. Has moderate or severe dementia
3. Able to walk 10 yards securely

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Established stroke with residual weakness
2. English not first language
3. Unstable medical condition
4. Type 1 Diabetes mellitus

Recruitment start date

21/10/2013

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

c/o Heather House
Clinical Trials and Research Governance Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

University/education

Funder name

University of Oxford

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator