Exploratory study of a ketogenic dietary supplement in dementia

Not Applicable

Completed

• Conditions: Dementia; Mental and Behavioural Disorders; Unspecified dementia

• Registration Number: ISRCTN39052741
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-05
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Ketone levels<br>2. Adverse events<br>3. Tolerability<br>4. Change in Severe Impairment Battery (SIB) at 8 days<br>5. Clinician Interview Based Impression of Change (CIBIC+)<br><br>Measured at baseline and one week only

Secondary Outcome Measures

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