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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01944436
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : April 13, 2016
Information provided by (Responsible Party):
Dr. Mario Masellis, Sunnybrook Health Sciences Centre

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
Lewy Body Disease Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)

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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 : September 2006
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. Change from baseline in perfusion brain SPECT at 6 months [ Time Frame: 0 and 6 months ]
  2. Change from baseline in neuropsychological assessment scores at 6 months [ Time Frame: 0 and 6 months ]

Secondary Outcome Measures :
  1. Volumetric Brain MRI [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA

Functional and tag SNPs in the following genes will be assessed:

acetylcholinesterase (ACHE); butyrylcholinesterase (BCHE); M1 muscarinic receptor (CHRM1); alpha7-nicotinic receptor (CHRNA7); Apolipoprotein E (ApoE); Cytochrome P450 2D6 (protein: CYP2D6 /gene: CYP2D6); CYP3A4; all genes related to blood pressure disregulation, white matter changes found on neuroimaging, and genes related to Lewy Body Spectrum disorders in general.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ontario, Canada.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01944436

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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Mario Masellis, Clinician-Scientist, Sunnybrook Health Sciences Centre Identifier: NCT01944436     History of Changes
Other Study ID Numbers: LBD-312-2006
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by Dr. Mario Masellis, Sunnybrook Health Sciences Centre:
Dementia with Lewy bodies
Adverse events
Parkinson's Disease Dementia
Cognitive enhancers
Clinical efficacy
Cytochrome P450

Additional relevant MeSH terms:
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Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Nootropic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Neuroprotective Agents
Protective Agents