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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01944436

Enrollment

Registered

2013-09-17

Start date

2006-09-30

Completion date

2016-01-31

Last updated

2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lewy Body Disease

Keywords

Pharmacogenomics, Dementia with Lewy bodies, Adverse events, Polymorphisms, Acetylcholinesterase, Parkinson's Disease Dementia, Cognitive enhancers, Clinical efficacy, Cytochrome P450, Butyrylcholinesterase

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.

Interventions

DRUGCholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Volumetric Brain MRI	Baseline

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026