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

ISRCTN	ISRCTN97133543
DOI	https://doi.org/10.1186/ISRCTN97133543
Protocol serial number	N/A
Sponsor	Jeroen Bosch Hospital (The Netherlands)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr P L J Dautzenberg
Scientific

Jeroen Bosch Hospital
Department of Geriatrics
P.O. Box 90153
Den Bosch
5200 ME
Netherlands

Phone	+31 (0)73 699 8629
Email	p.dautzenberg@jbz.nl

Primary study design	Interventional
Study design	Non-randomised, clinical trial
Secondary study design	Single-centre
Scientific title
Study acronym	LaTiNN
Study objectives	Specific behavioural symptoms of dementia needs specific treatment. In cases, levetiracetam seems to be effective in non-psychotic and non-depressive behavioural symptoms of dementia.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Dementia
Intervention	500 mg Levetiracetam/day to a maximum 1500 mg Levetiracetam/day.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Levetiracetam
Primary outcome measure(s)	Effect on week four and 13 compared to base-line on: 1. Behavioural symptoms (NPI and Cohen-Mansfield Agitation Inventory [CMAI]) 2. Care-giver burden (CBI) 3. Clinical impression (Global Clinical Impression [GCI])
Key secondary outcome measure(s)	Effect on week four and 13 compared to base-line on: 1. Cognition (Mini Mental State Examination [MMSE]) 2. Activities in Daily Living (ADL) (Interview for Deterioration in Daily living activities in Dementia [IDDD])
Completion date	01/04/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	25
Key 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
Key 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
Date of first enrolment	01/08/2006
Date of final enrolment	01/04/2007

Jeroen Bosch Hospital

Den Bosch
5200 ME
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/06/2005		Yes	No