Dementia Nervous System Diseases Dementia in Alzheimer's disease
Conditions
Interventions
1. Low dose melatonin
2. Placebo
Sponsors
NHS R&D Regional Programme Register - Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged over 65 years. Either gender. 2. Clinical Diagnostic Statistical Manual, IV edition (DSM-IV). Axix I diagnosis of dementia of Alzheimer's type. 3. Inpatients or patients living at home and managed by carers.
Exclusion criteria
Exclusion criteria: Does not match inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. An improvement in patents sleep quality and duration with melatonin compared with placebo. 2. An improvement in carers quality of life because if less disruption by restless patients. 3. A decrease in need for other more potent medications with significant side effects. The main outcome measure used will be improvement in length of sleep and a decrease in periods of nocturnal wakening for the periods 10 pm and 8 am. Objective measures will be made using a validated sleep activity and pulse logger (Somnitor) (Cole et al 1992). Subsidiary outcome measures will include: recordings of sleep using a sleep diary ratings on quality of sleep using Visual Analogue Scales, carer rating scales and the use of prescribed hypnotic medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed