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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR787 |
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Date of registration:
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08/08/2006 |
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Primary sponsor: |
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Public title:
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Levetiracetam for Treatment of Non-psychotic and Non-depressive behavioural symptoms of dementia.
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Scientific title:
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Levetiracetam for Treatment of Non-psychotic and Non-depressive behavioural symptoms of dementia. - LaTiNN |
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Date of first enrolment:
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1/8/2006 |
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Target sample size:
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25 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=787 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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P.L.J.
Dautzenberg |
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Address:
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Jeroen Bosch Hospital, Department Geriatrics,
P.O. Box 90153
5200 ME
Den Bosch
The Netherlands |
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Telephone:
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+31 (0)73 6998629 |
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Email:
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p.dautzenberg@jbz.nl |
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Affiliation:
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Name:
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P.L.J.
Dautzenberg |
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Address:
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Jeroen Bosch Hospital, Department Geriatrics,
P.O. Box 90153
5200 ME
Den Bosch
The Netherlands |
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Telephone:
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+31 (0)73 6998629 |
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Email:
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p.dautzenberg@jbz.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Dementia
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Intervention(s)
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500 mg Levetiracetam/day, maximum 1500 mg Levetiracetam/day.
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Primary Outcome(s)
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Effect on week 4 and 13 compared to base-line on Behauvioral symptoms (NPI and CMAI), care-giver burden (CBI) and clinical impression (GCI).
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Secondary Outcome(s)
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Effect on week 4 and 13 compared to base-line on cognition (MMSE) and ADL (IDDD).
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Secondary ID(s)
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ISRCTN97133543
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N/A
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Source(s) of Monetary Support
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UCB for support for statistical analysis if needed, however Dep geriatrics Utrecht University (Rob van Marum) will first performe this analysis
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