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

April 12, 2016 updated by: Dr. Mario Masellis, Sunnybrook Health Sciences Centre

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ontario, Canada.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in perfusion brain SPECT at 6 months
Time Frame: 0 and 6 months
0 and 6 months
Change from baseline in neuropsychological assessment scores at 6 months
Time Frame: 0 and 6 months
0 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Volumetric Brain MRI
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBD-312-2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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