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 Alzheimers 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
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