Dementia Mental and Behavioural Disorders Unspecified dementia
Conditions
Interventions
All participants will receive oral 25g D-ß-hydroxybutyrate-R 1,3 butanediol three times daily for a week. There are no control groups.
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Established stroke with residual weakness 2. English not first language 3. Unstable medical condition 4. Type 1 Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed