Parkinson DiseasePhase 2NCT05709301
Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
A Phase 2 study testing Donepezil Hydrochloride in people with Parkinson Disease and Mild Cognitive Impairment, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Phase II, multi-centric, randomized, double-blinded, placebo-controlled, parallel design clinical trial to evaluate the safety, tolerability and efficacy of Donepezil in patients with Mild Cognitive Impairment in Parkinson's Disease (PD-MCI). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment
- What is being tested?
- Donepezil Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-80
- PD diagnosis according to MDS criteria
- Hoehn and Yahr stage I-III
- Persistent subjective cognitive complaints for at least 6 months
- MDS PD-MCI Level I and Level II criteria
- Persistent PD-MCI for at least 3 months
- Stable dopaminergic treatment for at least 1 month
Who cannot join
- PD dementia criteria
- Severe motor complications
- DBS or any brain condition that may be contributing to cognitive impairment
- Active psychosis, major hallucinations, HADS ≥11, active impulse control disorder, or other active severe behavioral disorders.
- Treatment under anticholinergics, cholinergic enhancers, or neuroleptics.
- History of symptomatic arterial hypotension.
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- Hypersensitivity or intolerance to donepezil or any of the excipients
- Pregnancy
- Unstable medical or surgical condition
- Any other significant observation that, in the investigator's opinion, would contraindicate participation in the study.
About this study
Official title: Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Phase II, multi-centric, randomized, double-blinded, placebo-controlled, parallel design clinical trial to evaluate the safety, tolerability and efficacy of Donepezil in patients with Mild Cognitive Impairment in Parkinson's Disease (PD-MCI). A total of 120 patients with PD-MCI will be randomized to 12 months of oral Donepezil 10mg or matching placebo (1:1).
Primary and co-primary efficacy endpoints are cognitive and functional cognitive scales: PD-CRS and PD-CFRS. Secondary efficacy endpoints include: cognitive tests evaluating attention, executive functions, language, memory and visuospatial domain; mood, anxiety, and apathy scales; questionnaires to evaluate quality of life; and subjective impression scales. Serum Neurofilament light chain, genetic screening of GBA, ApoE and MAPT, and Magnetic Resonance Imaging will be performed in a subset of these patients.
The study will be conducted in 20 different centers around Spain. The Movement Disorders Unit of the Neurology Department at Sant Pau Hospital (Barcelona, Spain) will be the coordinating center.
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Being tested
- Donepezil Hydrochloride, Placebo
- Keywords
- Parkinson's Disease-Mild Cognitive Impairment (PD-MCI), Donepezil, Randomized Clinical Trial (RCT)
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HydrochlorideDrug
Donepezil 10mg once daily
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Experimental | Not described Receives: Drug: Donepezil Hydrochloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
Global cognition
Measured: 12 months
Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
Cognitive functional performance
Measured: 12 months
Secondary outcomes (18)
Trail Making Test A (TMT-A)
Attention
Measured: 12 months
TMT-B
Executive functions
Measured: 12 months
Boston Naming Test
Language
Measured: 12 months
Free and cued selective reminding test
Memory
Measured: 12 months
Rey-Osterrieth complex figure test (ROCF)
Visuospatial
Measured: 12 months
Hospital Anxiety and Depression Scale
Depression and Anxiety
Measured: 12 months
Starkstein Apathy scale
Apathy
Measured: 12 months
Neuropsychiatric Inventory
Hallucinations
Measured: 12 months
Schwab & England scale
Quality of life
Measured: 12 months
Clinical Global Impressions-Severity of illness
Subjective clinical change
Measured: 12 months
CGI-Global improvement
Subjective clinical change
Measured: 12 months
Patient Global Impression of Change
Subjective clinical change
Measured: 12 months
8-item Parkinson's Disease Questionnaire
Quality of life
Measured: 12 months
Judgment of Line Orientation
Visuspatial
Measured: 12 months
recall of ROCF
Memory
Measured: 12 months
Category fluency
Language
Measured: 12 months
Phonemic Fluency
Executive functions
Measured: 12 months
direct Digit Span
Attention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709301
- Sponsor's protocol ID
- IIBSP-DON-2022-43
- Status last verified
- Sep 2023
- First submitted
- 11 Jan 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05709301
- Acronym / sponsor ID
- IIBSP-DON-2022-43
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Keywords
- Parkinson's Disease-Mild Cognitive Impairment (PD-MCI), Donepezil, Randomized Clinical Trial (RCT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II, multi-centric, randomized, double-blinded, placebo-controlled, parallel design clinical trial to evaluate the safety, tolerability and efficacy of Donepezil in patients with Mild Cognitive Impairment in Parkinson's Disease (PD-MCI). A total of 120 patients with PD-MCI will be randomized to 12 months of oral Donepezil 10mg or matching placebo (1:1).
Primary and co-primary efficacy endpoints are cognitive and functional cognitive scales: PD-CRS and PD-CFRS. Secondary efficacy endpoints include: cognitive tests evaluating attention, executive functions, language, memory and visuospatial domain; mood, anxiety, and apathy scales; questionnaires to evaluate quality of life; and subjective impression scales. Serum Neurofilament light chain, genetic screening of GBA, ApoE and MAPT, and Magnetic Resonance Imaging will be performed in a subset of these patients.
The study will be conducted in 20 different centers around Spain. The Movement Disorders Unit of the Neurology Department at Sant Pau Hospital (Barcelona, Spain) will be the coordinating center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil | Experimental | Drug: Donepezil Hydrochloride |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 50-80
- PD diagnosis according to MDS criteria
- Hoehn and Yahr stage I-III
- Persistent subjective cognitive complaints for at least 6 months
- MDS PD-MCI Level I and Level II criteria
Key exclusion criteria (10 listed)
- PD dementia criteria
- Severe motor complications
- DBS or any brain condition that may be contributing to cognitive impairment
- Active psychosis, major hallucinations, HADS ≥11, active impulse control disorder, or other active severe behavioral disorders.
- Treatment under anticholinergics, cholinergic enhancers, or neuroleptics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil HydrochlorideDonepezil 10mg once daily | Drug | Donepezil |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
Time frame: 12 months
Global cognition
Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
Time frame: 12 months
Cognitive functional performance
18 secondary outcomes
Trail Making Test A (TMT-A)
Time frame: 12 months
TMT-B
Time frame: 12 months
Boston Naming Test
Time frame: 12 months
Free and cued selective reminding test
Time frame: 12 months
Rey-Osterrieth complex figure test (ROCF)
Time frame: 12 months
Hospital Anxiety and Depression Scale
Time frame: 12 months
Starkstein Apathy scale
Time frame: 12 months
Neuropsychiatric Inventory
Time frame: 12 months
Schwab & England scale
Time frame: 12 months
Clinical Global Impressions-Severity of illness
Time frame: 12 months
CGI-Global improvement
Time frame: 12 months
Patient Global Impression of Change
Time frame: 12 months
8-item Parkinson's Disease Questionnaire
Time frame: 12 months
Judgment of Line Orientation
Time frame: 12 months
recall of ROCF
Time frame: 12 months
Category fluency
Time frame: 12 months
Phonemic Fluency
Time frame: 12 months
direct Digit Span
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil Hydrochloride in people with Parkinson Disease and Mild Cognitive Impairment, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Disease-Cognitive Rating Scale (PD-CRS) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.