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

N/ACompletedNCT01944436

Sunnybrook Health Sciences Centre57 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lewy Body Disease

Interventions

Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)DRUG

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from baseline in perfusion brain SPECT at 6 months

Time frame: 0 and 6 months

Change from baseline in neuropsychological assessment scores at 6 months

Time frame: 0 and 6 months

Secondary Outcomes

Volumetric Brain MRI

Time frame: Baseline