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ADAPT: Treatment of Agitated behaviour in patients with Dementia non-responsive to guideline recommended interventions by Argued Personalised Treatment using an N-of-1 approach

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510601-29-00
Enrollment
100
Registered
2025-04-07
Start date
2025-07-23
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitated behaviour, Dementia

Brief summary

Agitation over time measured on the Cohen Mansfield Agitation Inventory (CMAI) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.

Detailed description

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., Frequency, severity, and burden of targeted agitated behaviour over time under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment., The incidence and severity of side effects under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.

Interventions

DRUGLORAZEPAM
DRUGOLANZAPINE
DRUGQUETIAPINE
DRUGMatching placebo capsules of quetiapine 25mg
DRUGolanzapine 2.5mg
DRUGand lorazepam 0.5mg will be produced. The placebo capsules will be filled with microcrystalline cellulose ph102 only.

Sponsors

Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Agitation over time measured on the Cohen Mansfield Agitation Inventory (CMAI) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.—

Secondary

MeasureTime frame
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., Frequency, severity, and burden of targeted agitated behaviour over time under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment., The incidence and severity of side effects under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026