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

Lewy Body Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944436
• Other study ID #: LBD-312-2006
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: April 12, 2016
• Start date: September 2006
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lewy Body Disease

Intervention

Drug:
• Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in perfusion brain SPECT at 6 months		0 and 6 months	No
Primary	Change from baseline in neuropsychological assessment scores at 6 months		0 and 6 months	No
Secondary	Volumetric Brain MRI		Baseline	No