Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1

Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 - EDAP-2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010778

Enrollment

Registered

2013-05-22

Start date

2013-04-10

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 donepezil hydrocloride

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants of EDAP-1 in Utano National Hosptial who have completed EDAP-1. 2. Both in-patients and out-patients. 3. Both females and males. 4. Age of 20 or elder (at IC obtaining) 5. Patients who give written informed consent. 6. Patients who are able to follow the study principles and to report their symptoms.

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.Patients who are diagnosed as possible or probable diffuse Lewy body disease according to the diagnostic criteria (shown in the protocol). 4.. Patients who have been diagnosed as schizophrenia. 5. Patients with previous history of the stereotaxic brain operation. 6. Patients with allergy to pyperidium derivatives. 7. Severe hepatic or renal dysfunction. 8. Patients with sick sinus syndrome or intra-atrial or AV nodal block (such as SA block or AV block of grade II or severer). 9. Patients with present or previous illness of severe gastrointestinal ulcer, severe bronchial asthma, or obstructive pulmonary disease. 10. Bradycardia (heart rate: 45 /min or less.) in the ECG at Visit 1. 11. QT elongation (QTc: >460msec) in the ECG at Visit 1. 12. Patients who are pregnant or feeding a baby. 13.Patients who are diagnosed as having malignancy 14. Patients who are judged as inappropriate for the enrolling to the trial by investigators.

Design outcomes

Primary

Measure	Time frame
Change of MMSE scores at the last visit from the basline scores of EDAP-1	—

Secondary

Measure	Time frame
Changes of Parkinson Psychosis Questionaire, Frontal Assessment Battery, and WMS-R from the baseline scores of EDAP-1	—

Countries

Japan

Contacts

Public ContactHideyuki Sawada

National Hospital of Utano Clinical Research Center

sawada.unh@gmail.com075-461-5121

Outcome results

None listed

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