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Evaluation of the effect of adding cyproterone acetate to quetiapine in reducing the Agitation and aggressive behavior of patients with Alzheimer's dementia

Evaluation of the effect of adding cyproterone acetate to quetiapine in reducing the Agitation and aggressive behavior of patients with Alzheimer's dementia. A randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220109053673N1
Enrollment
50
Registered
2025-04-10
Start date
2025-05-05
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Alzheimer. Alzheimers disease

Interventions

Intervention 1: Intervention group: Cyproterone acetate 50 mg every night for two weeks and increasing to 100 mg every night from the second to the sixth week. Intervention 2: Control group: One place

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Having a diagnosis of Probable AD based on NIA-AA criteria At least two years have passed since the onset of the disease Having a diagnosis of agitated behaviors Cohen-Mansfield Agitation Inventory (CAMI) score of 45 and above Having a reliable companion who gives appropriate information about the patient Providing written consent to enter the study

Exclusion criteria

Exclusion criteria: Simultaneous treatment with other antipsychotics and antidepressants (if used before starting the study, these drugs should be stopped and the washout period should be considered appropriate) The criticality of the patient's behavioral state (thoughts of harming oneself or others) that does not allow randomization Any contraindications for prescribing cyproterone acetate

Design outcomes

Primary

MeasureTime frame
Aggression score above 45 in Cohen-Mansfield Agitation Inventory (CMAI). Timepoint: Measuring aggression with the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire at the beginning of the study (before the start of the intervention) and 4 and 6 weeks after the start of the study. Method of measurement: Aggression score above 45 in Cohen-Mansfield Agitation Inventory (CMAI).

Countries

Central African Republic, Iran (Islamic Republic of)

Contacts

Public ContactNiloufar Nasrabadi

University of social welfare and rehabilitation sciences

niloufar.nasrabadi@gmail.com+98 21 4486 0252

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026