A Genetic and Perfusion Study of Response to Cognitive Enhancers in Lewy Body Disease

Completed

• Conditions: Lewy Body Disease
• Interventions: Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)

• Registration Number: NCT01944436
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

Lewy body spectrum disorders are a common group of neurodegenerative diseases that cause memory loss, behavioural and motor disabilities that impair quality of life. Cognitive enhancers help people afflicted with these conditions. However, some people do not benefit from this treatment, while others experience serious side effects. Side effects and poor response lead to hospitalization and early institutionalization. Pharmacogenomics, the study of how DNA variation can influence drug effects, will be combined with functional changes in brain imaging in response to cognitive enhancers in patients with Lewy body disease. The goal is to develop a predictive test that can be administered in the clinic to aid physicians' choice of initial medication. This can reduce health care costs and improve treatment to Canadians suffering from these devastating disorders.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Inclusion criteria for patients with a Lewy body spectrum disorder includes: age > 50 years; and mild-moderate dementia (Mini-Mental State Exam [MMSE] > 9); contact on at least four of seven days/week with a responsible caregiver; Hoehn & Yahr stage ≤ 4.

Exclusion Criteria

• age < 50; Severe dementia (MMSE < 9); contact < 4 days a week with a responsible caregiver; Hoehn & Yahr stage > 4.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dementia with Lewy Bodies	Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)	Participants in the Dementia with Lewy Bodies group: * Diagnosis of clinically probable or possible Dementia with Lewy bodies with at least 1 of the following: Marked fluctuations in cognition, visual hallucinations or spontaneous parkinsonism. * Response to cholinesterase inhibitor over a period of six months will be monitored.
Parkinson's Disease Dementia	Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)	Participants in the Parkinson's Disease Dementia group: * Must be taking a stable parkinsonian medication * Must have a diagnosis of clinically definite Parkinson's disease \>1 year prior to cognitive deficit with at least two of the following symptoms: asymmetric resting tremor, rigidity or bradykinesia, and definite motor response to dopaminergic agents. * Response to cholinesterase inhibitor over a period of six months will be monitored.

Primary Outcome Measures

Name	Time	Method
Change from baseline in neuropsychological assessment scores at 6 months	0 and 6 months
Change from baseline in perfusion brain SPECT at 6 months	0 and 6 months

Secondary Outcome Measures

Name	Time	Method
Volumetric Brain MRI	Baseline

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada