Clinical trial • Neurology|Psychiatry

LORAZEPAM for Dementia | Agitated behaviour

Clinical trial of LORAZEPAM for Dementia | Agitated behaviour.

Overview

Trial Therapeutic Area
Neurology|Psychiatry
Trial Disease
Dementia | Agitated behaviour
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-01-2025
First CTIS Authorization Date
07-04-2025

Trial design

Quetiapine (oral, max daily dose 50 mg as recorded), Olanzapine (oral, max daily dose 10 mg as recorded), Lorazepam (oral, max daily dose 2 mg as recorded); matching placebo capsules corresponding to quetiapine 25 mg, olanzapine 2.5 mg and lorazepam 0.5 mg are produced as placebo comparators. No schedule explicitly stated in the CTIS data.-controlled, crossover trial in Netherlands.

Comparator
Quetiapine (oral, max daily dose 50 mg as recorded), Olanzapine (oral, max daily dose 10 mg as recorded), Lorazepam (oral, max daily dose 2 mg as recorded); matching placebo capsules corresponding to quetiapine 25 mg, olanzapine 2.5 mg and lorazepam 0.5 mg are produced as placebo comparators. No schedule explicitly stated in the CTIS data.
Crossover
Yes
Target Sample Size
100

Eligibility

Recruits 100 Vulnerable population: nursing home residents with dementia. Informed consent may be provided by the patient's representative; documents for representatives are provided (L1_SIS and ICF Vertegenwoordiger for olanzapine, lorazepam and quetiapine). An optional participant ICF and an information video (Dutch) are available. The eligibility/exclusion criteria note that insufficient mastery of Dutch applies to representatives if they provide informed consent; shared decision-making with patient and/or representative is required for prescribing the study drugs..

Vulnerable Population
Vulnerable population: nursing home residents with dementia. Informed consent may be provided by the patient's representative; documents for representatives are provided (L1_SIS and ICF Vertegenwoordiger for olanzapine, lorazepam and quetiapine). An optional participant ICF and an information video (Dutch) are available. The eligibility/exclusion criteria note that insufficient mastery of Dutch applies to representatives if they provide informed consent; shared decision-making with patient and/or representative is required for prescribing the study drugs.

Inclusion criteria

  • {"criterion_text":"- Nursing home resident with dementia and agitated behaviour"}
  • {"criterion_text":"- The treating physician has decided to prescribe quetiapine, olanzapine or lorazepam, in shared decision making with the patient and/or representative, independently of this trial."}

Exclusion criteria

  • {"criterion_text":"- A life expectancy of <4 weeks, as estimated by the physician"}
  • {"criterion_text":"- Inability to swallow the study capsules, assessed by the physician"}
  • {"criterion_text":"- Actual alcohol and/or drug abuse"}
  • {"criterion_text":"- The agitated behaviour is too unstable, as estimated by the physician"}
  • {"criterion_text":"- Insufficient mastery of Dutch language, also applies to representatives if they provide informed consent"}
  • {"criterion_text":"- The agitated behaviour is only present at night"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Agitation over time measured on the Cohen Mansfield Agitation Inventory (CMAI) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.","definition_or_measurement_approach":"Measured using the Cohen Mansfield Agitation Inventory (CMAI) over time comparing psychotropic drug treatment (quetiapine, olanzapine or lorazepam) versus placebo."}

Secondary endpoints

  • {"endpoint_text":"- Agitation over time measured on the Clinical Global Impression of Severity (CGI-S) and the Clinical Global Impression of Change (CGI-C) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.","definition_or_measurement_approach":"Measured using Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Change (CGI-C) over time comparing drug treatment versus placebo."}
  • {"endpoint_text":"- Frequency, severity, and burden of targeted agitated behaviour over time under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.","definition_or_measurement_approach":"Assessment of frequency, severity and burden of targeted agitated behaviour over time comparing drug treatment versus placebo (as specified in protocol)."}
  • {"endpoint_text":"- The incidence and severity of side effects under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.","definition_or_measurement_approach":"Incidence and severity of adverse events/side effects recorded and compared between drug treatment and placebo arms."}

Recruitment

Planned Sample Size
100
Recruitment Window Months
24
Consent Approach
Informed consent may be provided by the patient or by a legal representative. Subject information and informed consent forms for representatives are provided (L1_SIS and ICF Vertegenwoordiger for olanzapine, lorazepam and quetiapine). An optional participant ICF is available and an information video in Dutch (L2 Information Video - Dutch) is provided. The protocol notes shared decision-making with the patient and/or representative. Insufficient mastery of Dutch excludes participation and this also applies to representatives providing consent.

Geography

Total Number Of Sites
25
Total Number Of Participants
100

Netherlands

Earliest CTIS Part Ii Submission Date
10-03-2025
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
367
Number Of Sites
25
Number Of Participants
100

Sites

Site Name
Stichting Carint Reggeland
Department Name
Carint Reggeland
Contact Person Name
Dick Rijksen
Contact Person Email
d.rijksen@carintreggeland.nl
Site Name
Stichting Omring
Department Name
Omring
Contact Person Name
Ruth Samuels
Contact Person Email
ruth.samuels@omring.nl
Site Name
Stichting Vivium Zorggroep
Department Name
Vivium
Contact Person Name
Janine van Kooten
Contact Person Email
j.vankooten@vivium.nl
Site Name
Zorg- en Wooncentrum De Haven
Department Name
De Haven
Contact Person Name
Michelle Koch
Contact Person Email
mkoch@dehaven.nl
Site Name
Stichting Careyn
Department Name
Careyn
Contact Person Name
Esther de Heer-Dijkhuizen
Contact Person Email
E.dijkhuizen@careyn.nl
Site Name
Stichting Zorgspectrum
Department Name
Zorgspectrum
Contact Person Name
Marloes von Burg
Contact Person Email
ma.vonburg@zorgspectrum.nl
Site Name
Stichting Humanitas
Department Name
Humanitas
Contact Person Name
Linda Hooijschuur
Site Name
Dagelijks Leven
Department Name
Dagelijks Leven
Contact Person Name
Gert-Jan van der Putten
Site Name
Stichting Beweging 3.0
Department Name
Beweging 3.0
Contact Person Name
Lieke de Vijlder
Contact Person Email
lieke.devijlder@beweging3.nl
Site Name
Stichting Amsta
Department Name
Amsta
Contact Person Name
Esther Helmich
Contact Person Email
e.helmich@amsta.nl
Site Name
Stichting Woonzorggroep Samen
Department Name
Samen
Contact Person Name
Esther Zwaan
Contact Person Email
esther.zwaan@wzgsamen.nl
Site Name
Stichting Zinzia Zorggroep
Department Name
Zinzia
Contact Person Name
Marieke Meeuwis
Contact Person Email
marieke.meeuwis@zinzia.nl
Site Name
Stichting Aafje
Department Name
Aafje
Contact Person Name
Eline Molenaar
Contact Person Email
emolenaar@aafje.nl
Site Name
Stichting de Zorgcirkel
Department Name
Zorgcirkel
Contact Person Name
Ronald Kolder
Contact Person Email
ronald.kolder@zorgcirkel.nl
Site Name
Stichting Zorgbalans
Department Name
Zorgbalans
Contact Person Name
Simone Hendriks
Contact Person Email
s.hendriks@zorgbalans.nl
Site Name
Stichting Zorgcombinatie Marga Klompé
Department Name
Marga Klompé
Contact Person Name
Rini Eringfeld
Contact Person Email
r.eringfeld@szmk.nl
Site Name
Stichting Archipel Zorggroep
Department Name
Archipel
Contact Person Name
Peronneke Slaats
Site Name
Stichting De Waalboog
Department Name
Waalboog
Contact Person Name
Lizzy Harmsen
Contact Person Email
l.harmsen@dewaalboog.nl
Site Name
Zorgpartners Midden-Holland
Department Name
Zorgpartners
Contact Person Name
Margriet Leenen
Site Name
Stichting Careaz
Department Name
Careaz
Contact Person Name
Han van Meerten
Contact Person Email
h.vanmeerten@careaz.nl
Site Name
Stichting Sensire
Department Name
Sensire
Contact Person Name
Machteld Zoomer
Contact Person Email
m.zoomer@sensire.nl
Site Name
Stichting Zorggroep Noorderboog
Department Name
Noorderboog
Contact Person Name
Rianne Lindeboom
Contact Person Email
r.lindeboom@noorderboog.nl
Site Name
Land van Horne
Department Name
Land van Horne
Contact Person Name
Sander van Hoeve
Contact Person Email
s.van.hoeve@landvanhorne.nl
Site Name
Carinova
Department Name
Carinova
Contact Person Name
Pieter Stapelkamp
Contact Person Email
p.stapelkamp@carinova.nl
Site Name
Goudenhart
Department Name
Goudenhart
Contact Person Name
Kristel van Tol
Contact Person Email
k.vantol@goudenhart.nu

Sponsor

Primary sponsor

Full Name
Amsterdam UMC
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
LORAZEPAM
Active Substance
LORAZEPAM
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
2 mg (max daily dose amount recorded)
Investigational Product Name
QUETIAPINE
Active Substance
QUETIAPINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
50 mg (max daily dose amount recorded)
Investigational Product Name
OLANZAPINE
Active Substance
OLANZAPINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
10 mg (max daily dose amount recorded)
Investigational Product Name
Matching placebo capsules of quetiapine 25mg, olanzapine 2.5mg, and lorazepam 0.5mg
Active Substance
Microcrystalline cellulose PH102 (placebo filler)
Modality
Other
Routes Of Administration
ORAL
Route
ORAL

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