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Rivastigmine in the treatment of Sleep REM Behaviour Disorder (RBD) and Hallucinations in Parkinsonism: a Clinical and Polysomnographic study? - ND

Rivastigmine in the treatment of Sleep REM Behaviour Disorder (RBD) and Hallucinations in Parkinsonism: a Clinical and Polysomnographic study? - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-012071-10-IT
Enrollment
Unknown
Registered
2009-05-29
Start date
2009-06-15
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

PARKINSONISM MedDRA version: 9.1 Level: SOC Classification code 10029205 MedDRA version: 9.1 Level: HLT Classification code 10034005

Interventions

Trade Name: EXELON Pharmaceutical Form: Transdermal patch INN or Proposed INN: Rivastigmine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4.6- Pharmaceutical form

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Clinical and Polysomnographic diagnosis of RBD (REM Sleep Behavior Disorders) based on the ICD (International Classification of Sleep Disorders; 2005) criteria (Manual of the?American Academy of Sleep Medicine?) -Both Sex, age=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - MMSE<24 -Side intolerable effects referred to Rivastigmine -Gastric ulcer -Epileptic seizures -Urinary Occlusion -Sinus-node disease -Cardiac Conduction Defects (sino-atrial block; atrioventricular block) -Bronchopneumopathy Chronic obstructive (BPCO)

Design outcomes

Primary

MeasureTime frame
Main Objective: evaluate the efficacy of the Cholinesterase Inhibitor treatment in Parkinson?s disease patients with hallucinations and RBD non-responders to Antipsychotic and Clonazepam therapy;Secondary Objective: ND;Primary end point(s): questionnaire and 24 hours/EEG—

Countries

Italy

Outcome results

None listed

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