| - candidate number | 2201 |
| - NTR Number | NTR787 |
| - ISRCTN | ISRCTN97133543 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 8-aug-2006 |
| - Secondary IDs | N/A |
| - Public Title | Levetiracetam for Treatment of Non-psychotic and Non-depressive behavioural symptoms of dementia. |
| - Scientific Title | Levetiracetam for Treatment of Non-psychotic and Non-depressive behavioural symptoms of dementia. |
| - ACRONYM | LaTiNN |
| - 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. |
| - Healt Condition(s) or Problem(s) studied | Dementia |
| - Inclusion criteria | 1. Ambulant patients with dementia, level Reisberg 4-6; 2. Informant available.; 3. 6 weeks stable treatment of dementia; anti-psychotics and anti-depressants. |
| - Exclusion criteria | 1. NPI item hallucinations, delusions and depression > ;1 2. Epilepsia; 3. Alcoholism; 4. DM or thyroid disease not under control. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | Single arm |
| - Studytype | intervention |
| - planned startdate | 1-aug-2006 |
| - planned closingdate | 1-apr-2007 |
| - Target number of participants | 25 |
| - Interventions | 500 mg Levetiracetam/day, maximum 1500 mg Levetiracetam/day. |
| - Primary outcome | Effect on week 4 and 13 compared to base-line on Behauvioral symptoms (NPI and CMAI), care-giver burden (CBI) and clinical impression (GCI). |
| - Secondary outcome | Effect on week 4 and 13 compared to base-line on cognition (MMSE) and ADL (IDDD). |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Dr. P.L.J. Dautzenberg |
| - CONTACT for SCIENTIFIC QUERIES | Dr. P.L.J. Dautzenberg |
| - Sponsor/Initiator | Jeroen Bosch Hospital, Department of Geriatrics |
| - Funding (Source(s) of Monetary or Material Support) | UCB for support for statistical analysis if needed, however Dep geriatrics Utrecht University (Rob van Marum) will first performe this analysis |
| - Publications | 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. |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 8-aug-2006 - 24-nov-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl