Predicting response to treatment in early Lewy body disease

Eligibility criteria

Inclusion Criteria:
1. Aged over 60 years
2. MoCA  <26
3. Lewy Body Disease with cognitive impairment (one of the following):
3.1. PD-MCI: Meeting Level 1 PD-MCI criteria (screening stage) and Level 2 PD-MCI criteria (baseline assessment stage) with deficits > 2 SD below normative levels, or
3.2. For LB-MCI: Meeting LB-MCI criteria, or
3.3. Mild PD dementia, or
3.4. Dementia with Lewy body
4. English as a first language or fluent command of the English language as defined by the assessor.
5. A spouse, close relative or well established carer to accompany the subject to act as an informant (minimum contact twice weekly) and ensure medication compliance
6. Cholinesterase inhibitor and memantine naïve (not on a Cholinesterase inhibitor or memantine for the preceding 3 months)
7. If on anti-parkinsonian regime to have been on a stable regimen for at least 2 months
Exclusion Criteria:
1. History of significant cerebrovascular disease
2. Presence of major cerebrovascular disease on brain imaging (severe leukoaraiosis or infarcts in strategic areas)
3. Other neurological diseases which may cause cognitive impairment e.g. a diagnosis of progressive supranuclear palsy, multiple system atrophy, or corticobasal degeneration, according to accepted diagnostic criteria
4. Presence of major depression
5. Physical co-morbidities including:  history of severe gastrointestinal ulceration, severe asthma or obstructive pulmonary disease; systolic hypotension (< 90 mmHg); bradycardia (< 50 beats per minute); sick sinus syndrome; atrial or atrioventricular conduction block; QT interval prolongation (> = 450 ms)
6. Use of cognitive enhancing medications (e.g. cholinesterase inhibitors, memantine)
7. High dose benzodiazepines, antipsychotics or anticonvulsants
8. Use of anticholinergics with significant central effects e.g. oxybutynin
9. Contraindications to MR scanning (e.g. inability to lie flat for 30 minutes, claustrophobia, inability to tolerate a previous similar procedure, MR incompatible pacemaker)
10. Severe kidney disease
11. History of deep brain stimulation
12. Unstable and/or significant medical comorbidity likely to interfere with compliance
13. Significant functional deficits likely to interfere with compliance
14. Severe parkinsonism (Hoehn and Yahr stage IV or above)
15. Hypersensitivity to donepezil or piperidine derivatives

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-09-21