Multicenter, randomized, double-blind, and placebo-controlled clinical trial to assess the efficacy and safety of donepezil versus placebo in mild cognitive impairment associated with Parkinson's disease.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510959-35-00

Acronym

IIBPS-DON-2022-43

Enrollment

120

Registered

2024-06-12

Start date

2023-09-07

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

Parkinson's disease

Brief summary

Parkinson's Disease-Cognitive Rating Scale (PD-CRS), Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)

Detailed description

Trail Making Test A (TMT-A), Digit Span directo (DSd), Trail Making Test B (TMT-B), Phonemic fluency, Boston Nomination Test reduced (BNTr), Semantic fluency, Free and Cued Selective Reminding Test (FCSRT), Figura compleja de Rey-Osterrieth (ROCF) y recuerdo de ROCF (rROCF), Judgement of Line Orientation (JLO), Hospital Anxiety and Depression Scale (HADS), Starkstein Apathy Scale (AS), Neuropsychiatric Inventory (NPI), MDS UPDRS-I y -II, Schwab & England scale (S&E):, 8-item Parkinson’s Disease Questionnaire (PDQ-8), Clinical Global Impressions (CGI-S y CGI-I), Patients Global Impression of Change (PGIC)

Interventions

DRUGARICEPT 10mg comprimidos recubiertos con película

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Parkinson's Disease-Cognitive Rating Scale (PD-CRS), Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)	—

Secondary

Measure	Time frame
Trail Making Test A (TMT-A), Digit Span directo (DSd), Trail Making Test B (TMT-B), Phonemic fluency, Boston Nomination Test reduced (BNTr), Semantic fluency, Free and Cued Selective Reminding Test (FCSRT), Figura compleja de Rey-Osterrieth (ROCF) y recuerdo de ROCF (rROCF), Judgement of Line Orientation (JLO), Hospital Anxiety and Depression Scale (HADS), Starkstein Apathy Scale (AS), Neuropsychiatric Inventory (NPI), MDS UPDRS-I y -II, Schwab & England scale (S&E):, 8-item Parkinson’s Disease Questionnaire (PDQ-8), Clinical Global Impressions (CGI-S y CGI-I), Patients Global Impression of Change (PGIC)	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026