Parkinson'
Conditions
Interventions
Donepezil hydrochloride added to standard therapy
Placebo added to standard therapy
Sponsors
National Hospital Organization, Sendai-Nishitaga Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 55-75 years 2) Patients who developed Parkinson's disease at the age of 40 or older 3) Patients in Hoehn and Yahr stage 1 to 3 4) Patients who are with severe olfactory dysfunction (OSIT-J <=4) 5) Patients who agreed to participate in the study and signed written informed consent (Written informed consent provided by his/her family member is accepted if patients are not capable of giving a written informed consent but orally agreed to participate in the study
Exclusion criteria
Exclusion criteria: 1) Patients with a history of other neurological and/or psychological disorders which may influence motor and cognitive function 2) Patients with the presence of apparent local lesions on head MRI (Note that brain atrophy and white matter ischemia are granted as age-related physiological observation) 3) Patients who had taken anticholinergic drug or drug with an anticholinergic effect within 4 weeks prior to the registration 4) Patients with a symptom such as rhinitis and sinusitis which was considered to affect olfactory sense 5) Patients who need a treatment for depression, the score of >=3 in "1.3. Depressed Mood", the Japanese version of the MDS-UPDRS 6) Patients suspected of impairment in cognitive function (MMSE embedded in the ACE-R <26, or CDR >=1) 7) Patients with a history of hypersensitivity to Donepezil hydrochloride or piperidine derivative 8) Patients with complications of cardiac diseases such as sick sinus syndrome, conduction disturbance in intra-atrial and atrioventricular junction (e.g., sinoatrial block, second- or higher degree atrioventricular block) 9) Patient with a history of severe peptic ulcer 10) Patients with complications of or a history of severe bronchial asthma or obstructive pulmonary disease 11) Patients with a history of stereotaxic surgery or deep brain stimulation 12) Patient who were judged inappropriate for this study by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Parkinson's disease dementia | — |
Secondary
| Measure | Time frame |
|---|---|
| - ACE-R - CDR - Safety: adverse events, vital signs (blood pressure and pulse rate), laboratory test results, MDS-UPDRS | — |
Countries
Japan
Contacts
Public ContactAtsushi Takeda
National Hospital Organization, Sendai-Nishitaga Hospital Department of Neurology
Outcome results
None listed