Research with human participants

Overview of medical research in the Netherlands

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

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON23657

Source

NTR

Brief title

LaTiNN

Health condition

3 moths, prospective, open label trial

Sponsors and support

Primary sponsor :
Dep geriatrics JBZ
Hervensebaan 4
Postbus 1101 5200 BD Den Bosch
073-6998629
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
Maximum of € 10.000

Intervention

Outcome measures

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).

Background summary

N/A

Study objective

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.

Study design

N/A

Intervention

500 mg Levetiracetam/day, maximum 1500 mg Levetiracetam/day.

Public
Jeroen Bosch Hospital, Department Geriatrics,
P.O. Box 90153

P.L.J. Dautzenberg
Den Bosch 5200 ME
The Netherlands
+31 (0)73 6998629
p.dautzenberg@jbz.nl
Scientific
Jeroen Bosch Hospital, Department Geriatrics,
P.O. Box 90153

P.L.J. Dautzenberg
Den Bosch 5200 ME
The Netherlands
+31 (0)73 6998629
p.dautzenberg@jbz.nl

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.

Design

Study type :
Interventional
Intervention model
:
Other
Allocation :
Non controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
25
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL776
NTR-old NTR787
Other : N/A
ISRCTN ISRCTN97133543

Summary results

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.