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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01944436

Collaborator

(none)

Enrollment

Location

112

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lewy Body Disease	Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)

Study Design

Study Type:

Observational

Actual Enrollment :

57 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Lewy Body Spectrum Disorders: Investigating Neuropsychiatric Benefit and Adverse Effects in Response to Cholinesterase Inhibitors Using Genetics and Brain SPECT

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Parkinson's Disease Dementia 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.	Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)
Dementia with Lewy Bodies 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.	Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)

Arm

Intervention/Treatment

Parkinson's Disease Dementia

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.

Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)

Dementia with Lewy Bodies

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.

Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)

Outcome Measures

Primary Outcome Measures

Change from baseline in perfusion brain SPECT at 6 months [0 and 6 months]
Change from baseline in neuropsychological assessment scores at 6 months [0 and 6 months]

Secondary Outcome Measures

Volumetric Brain MRI [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.