A Multi-center Randomized Placebo-controlled Double-blinded Study for the Efficacy of Donepezil against Psychosis in Parkinson Disease

A Multi-center Randomized Placebo-controlled Double-blinded Study for the Efficacy of Donepezil against Psychosis in Parkinson Disease - EDAP study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005403

Enrollment

142

Registered

2011-04-08

Start date

2011-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Parkinson disease

Interventions

5mg of donepezil hydrochloride placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) UK brain bank Parkinson's disease diagnostic criteria (steps 1 and 2) 2) modified Hoehn-Yahr stages (2.5, III, IV) 3) Previous history of hallucinations, delirium, or dlusions 4) Not taking donepezil hydrochloride or other AchE inhibitors in the preceding 4 weeks. 5) Subjects who gave the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Past use of donepezil hydrochloride. 2. Use of an inhibitor of brain acetylcholine esterase (listed in the protocol) in the 4 weeks before Visit 2. 3. Use of Yoku-Kan-San in the 4 weeks before Visit 4. 4. Use of anti-psychotic drugs (listed in the protocol) in the 12 weeks before Visit 2. 5. Patients who are diagnosed as possible or probable diffuse Lewy body disease according to the diagnostic criteria (shown in the protocol). 6. Patients who have been diagnosed as schizophrenia 7. Patients with previous history of the stereotaxic brain operation 8. Patients with allergy to pyperidium derivatives. 9. Severe hepatic or renal dysfunction (Grade 3 in the protocol). 10. Patients with sick sinus syndrome or intra-atrial or AV nodal block (such as SA block or AV block of grade II or severer). 11. Patients with present or previous illness of severe gastrointestinal ulcer, severe bronchial asthma, or obstructive pulmonary disease. 12. Bradycardia (heart rate: 45 /min or less.) in the ECG at Visit 1. 13. QT elongation (QTc: >460msec) in the ECG at Visit 1. 14. Patients who are pregnant or feeding a baby. 15. Patients who participated in the other clinical trial in the 12 weeks before Visit 2. 16. Patients who are diagnosed as having malignancy 17. Patients who are judged as inappropriate for the enrolling to the trial by investigators.

Design outcomes

Primary

Measure	Time frame
Time to the occurence of psychosis	—

Secondary

Measure	Time frame
Other outcomes that are defined in the study protocol	—

Countries

Japan

Contacts

Public ContactHideyuki Sawada

Utano National Hospital, National Hospital Organization Clinical Research Center

sawada@unh.hosp.go.jp81-75-461-5121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026