Condition category
Mental and Behavioural Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
28/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P L J Dautzenberg

ORCID ID

Contact details

Jeroen Bosch Hospital
Department of Geriatrics
P.O. Box 90153
Den Bosch
5200 ME
Netherlands
+31 (0)73 699 8629
p.dautzenberg@jbz.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

LaTiNN

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Non-randomised, clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Dementia

Intervention

500 mg Levetiracetam/day to a maximum 1500 mg Levetiracetam/day.

Intervention type

Drug

Phase

Not Specified

Drug names

Levetiracetam

Primary outcome measures

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])

Secondary outcome measures

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])

Overall trial start date

01/08/2006

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

25

Participant 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

Recruitment start date

01/08/2006

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Jeroen Bosch Hospital
Den Bosch
5200 ME
Netherlands

Sponsor information

Organisation

Jeroen Bosch Hospital (The Netherlands)

Sponsor details

Department of Geriatrics
P.O. Box 1101
Den Bosch
5200 BD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.jeroenboschziekenhuis.nl/jbz/jbz_patient

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Dautzenberg PLJ et al. Medicamenteuze behaneling van gedrags- en psychische problemen bij dementie (BPSD). Tijdschrift voor verpleeghuisgeneeskunde 2003;27(5):5-9.
Weiner MF et al. Levetiracetam for agitated Alzheimer's disease patients. Int J Psychogeriatrics 2005;17(2):327-8.

Publication citations

Additional files

Editorial Notes