Dementia, Lewy body disease Nervous System Diseases
Conditions
Interventions
Briefly, after providing informed consent, participants will complete:
1. A screening assessment - determines suitability to be included in the study. Participants with possible cognitive impairment d
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged over 60 years 2. MoCA 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
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 ( = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Biomarkers (EEG, blood tests) at baseline, 8 weeks and 16 weeks. Further biomarkers (MRI, Gait assessments, Short afferent inhibition (SAI) and wearable activity monitor) at 8 weeks and 16 weeks 2. Power of attention time, PoA, (summation of simple choice reaction and digit vigilance time derived from the computerised attention battery) at baseline, 8 weeks and 16 weeks. These tests are repeated after 6 months if participants choose to continue active treatment 3. Cognitive function measured using Montreal Cognitive Assessment (MoCA) at baseline, 8 weeks and 16 weeks. This test is repeated after 6 months if participants choose to continue active treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measures of cognitive fluctuations (clinical assessment of fluctuations scale) at baseline, 8 weeks and 16 weeks. This test is repeated after 6 months if participants choose to continue active treatment 2. Gait function (step-time variability, gait speed, fall frequency) completed at 8 weeks and 16 weeks 3. Neuropsychiatric symptoms (Neuropsychiatric inventory) completed at baseline, 8 weeks and 16 weeks. This test is repeated after 6 months if participants choose to continue active treatment | — |
Countries
England, United Kingdom
Outcome results
None listed