Levetiracetam for Treatment of Non-psychotic and Non-depressive behavioural symptoms of dementia
| ISRCTN | ISRCTN97133543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97133543 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 28/12/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr P L J Dautzenberg
Scientific
Scientific
Jeroen Bosch Hospital
Department of Geriatrics
P.O. Box 90153
Den Bosch
5200 ME
Netherlands
| Phone | +31 (0)73 699 8629 |
|---|---|
| p.dautzenberg@jbz.nl |
Study information
| Study design | Non-randomised, clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levetiracetam |
| Primary outcome measure | 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 study start date | 01/08/2006 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Jeroen Bosch Hospital
Den Bosch
5200 ME
Netherlands
5200 ME
Netherlands
Sponsor information
Jeroen Bosch Hospital (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Geriatrics
P.O. Box 1101
Den Bosch
5200 BD
Netherlands
| Website | http://www.jeroenboschziekenhuis.nl/jbz/jbz_patient |
|---|---|
"ROR" |
https://ror.org/04rr42t68 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2005 | Yes | No |
