evetiracetam for Treatment of Non-psychotic and Non-depressive behavioural symptoms of dementia

Completed

• Conditions: Dementia; Mental and Behavioural Disorders; Mental disorders

• Registration Number: ISRCTN97133543
• Lead Sponsor: Jeroen Bosch Hospital (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Ambulant patients with dementia, level Reisberg four to six
2. Informant available
3. Six weeks stable treatment of dementia, anti-psychotics and anti-depressants

Exclusion Criteria

1. Neuropsychiatric Inventory (NPI) item hallucinations, delusions and depression more than one
2. Epilepsia
3. Alcoholism
4. Diabetes Mellitus (DM) or thyroid disease not under control

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect on week four and 13 compared to base-line on:<br>1. Behavioural symptoms (NPI and Cohen-Mansfield Agitation Inventory [CMAI])<br>2. Care-giver burden (CBI) <br>3. Clinical impression (Global Clinical Impression [GCI])

Secondary Outcome Measures

Name	Time	Method
Effect on week four and 13 compared to base-line on:<br>1. Cognition (Mini Mental State Examination [MMSE])<br>2. Activities in Daily Living (ADL) (Interview for Deterioration in Daily living activities in Dementia [IDDD])