Lewy Body DiseaseNCT01944436
A Genetic and Perfusion Study of Response to Cognitive Enhancers in Lewy Body Disease
An observational study of Lewy Body Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lewy Body Disease
- What is being tested?
- Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ontario, Canada.
Who may be able to join
- 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.
Who cannot join
- age < 50; Severe dementia (MMSE < 9); contact < 4 days a week with a responsible caregiver; Hoehn \& Yahr stage > 4.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lewy Body Disease
- Being tested
- Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)
- Keywords
- Pharmacogenomics, Dementia with Lewy bodies, Adverse events, Polymorphisms, Acetylcholinesterase, Parkinson's Disease Dementia, Cognitive enhancers, Clinical efficacy, Cytochrome P450, Butyrylcholinesterase
- Medical subject headings
- Lewy Body Disease, Pain, Butyrylcholinesterase deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in perfusion brain SPECT at 6 months
Measured: 0 and 6 months
Change from baseline in neuropsychological assessment scores at 6 months
Measured: 0 and 6 months
Secondary outcomes (1)
Volumetric Brain MRI
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2006
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DiseaseStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mario Masellis, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944436
- Sponsor's protocol ID
- LBD-312-2006
- Status last verified
- Apr 2016
- First submitted
- 10 Sep 2013
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lewy Body Spectrum Disorders: Investigating Neuropsychiatric Benefit and Adverse Effects in Response to Cholinesterase Inhibitors Using Genetics and Brain SPECT
- ClinicalTrials.gov ID
- NCT01944436
- Acronym / sponsor ID
- LBD-312-2006
- Conditions
- Lewy Body Disease
- Keywords
- Pharmacogenomics, Dementia with Lewy bodies, Adverse events, Polymorphisms, Acetylcholinesterase, Parkinson's Disease Dementia, Cognitive enhancers, Clinical efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Dementia | – | Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)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. |
| Dementia with Lewy Bodies | – | Drug: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ontario, Canada.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- age < 50; Severe dementia (MMSE < 9); contact < 4 days a week with a responsible caregiver; Hoehn \& Yahr stage > 4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine) | Drug | Dementia with Lewy Bodies, Parkinson's Disease Dementia |
Primary outcome
Change from baseline in perfusion brain SPECT at 6 months
Time frame: 0 and 6 months
Change from baseline in neuropsychological assessment scores at 6 months
Time frame: 0 and 6 months
1 secondary outcome
Volumetric Brain MRI
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lewy Body Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in perfusion brain SPECT at 6 months (time frame: 0 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.