Parkinson's disease
Conditions
Interventions
Trade Name: Aricept
Pharmaceutical Form: Tablet
INN or Proposed INN: Donepezil
CAS Number: 120014-06-4
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 10-
Pharmaceu
Sponsors
Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 50-80 years (included) - Diagnosis of PD based on MDS criteria(45) - Neuroimaging compatible with PD - Hoehn and Yahr Stadium (H&Y) I-III (included) - Persistent subjective cognitive complaints in the 6 months prior to Screening - Diagnosis of MCI-EP by MDS MCI-EP criteria: - Duration of DCL-EP of at least 3 months prior to Screening - Stable dopaminergic treatment in the 4 weeks prior to Screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Criteria for dementia associated with PD(49) - Severe motor complications (moderate-severe motor fluctuations defined as a score >1 on MDS UPDRS Part IV item 42; or disabling dyskinesias defined as a score >1 on MDS UPDRS Part IV item 36) - History of Deep Brain Stimulation - Active or antipsychotic psychosis, major hallucinations, HADS score =11, active impulse control disorder, or other active severe behavioral disorders - Active treatment with anticholinergics, acetylcholinesterase inhibitors or other systemic cholinergic enhancers, or neuroleptics - Hypersensitivity or intolerance to donepezil, to piperidine derivatives, to lactose or to any of the excipients of the active drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Safety: Evaluate the safety of donepezil administered for 12 months by measuring blood pressure (BP), heart rate (HR), blood tests, Movement Disorders Society Unified Parkinson's Disease Rating Scale part III (MDS UPDRS-III), ECG, and recording of adverse effects. • Primary efficacy: To assess the effects of donepezil administered for 12 months on global cognitive performance by analyzing changes in the Parkinson's Disease-Cognitive Rating Scale (PD-CRS) from baseline to 12 months.;Secondary Objective: - To assess the effects on cognitive functional performance by analyzing changes in the Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS) - Evaluate the effects in different tests and cognitive domains analyzing the changes in Trail Making Test A (TMT-A), Direct Digit Span (DSd), Trail Making Test B (TMT-B), Phonetic Fluency (FF), Boston Naming Test (BNTr), Semantic fluency (FS), Free and cued selective reminding test (FCSRT), Rey-Osterrieth complex figure test (ROCF), ROCF recall (rROCF), and Judgment of line orientation (JLO) - Evaluate the effects on anxiety, depression, apathy, psychosis, sleep and dysautonomia - Assess the effects on quality of life - Evaluate the effects on the severity and changes in the general clinical state of the patient, - To assess the effects on the subjective cognitive state by analyzing changes in the Patient Global Impression of Change (PGIC) scale.;Primary end point(s): Parkinson's Disease-Cognitive Rating Scale (PD-CRS):;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Trail Making Test A (TMT-A) Direct Digit Span (DSd) Trail Making Test B (TMT-B) Boston Nomination Test reduced (BNTr) phonetic fluency semantic fluency Free and Cued Selective Reminding Test (FCSRT) Hospital Anxiety and Depression Scale (HADS) Starkstein Apathy Scale (AS) Neuropsychiatric Inventory (NPI): MDS UPDRS-I and -II Schwab & England Scale (S&E) 8-item Parkinson's Disease Questionnaire (PDQ-8): Clinical Global Impressions (CGI-S and CGI-I) Patients Global Impression of Change (PGIC) Montreal Cognitive Assessment (MoCA);Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactUICEC Sant Pau
Institut de Recerca H. Santa Creu i Sant Pau
Outcome results
None listed