LRRK2 Mutation and Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01424475|
Recruitment Status : Terminated (Following extensive efforts to increase recruitment, it will not be possible to complete the study protocol within a reasonable time)
First Posted : August 29, 2011
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Genetic: Healthy Genetic: PKD Patients||Phase 1|
The Leucine-Rich Repeat Kinase 2 (LRRK2) is implicated in autosomal dominant Parkinson's disease (PKD). An inhibitor for the leucine-rich repeat kinase 2 (LRRK2) is in pre-clinical development for potential use in treating Parkinson's disease. Patients with PKD have cognitive impairments which develop alongside the typical motor symptoms but a full characterisation of the neurocognitive phenotype of PKD patients with LRRK2 mutation is currently lacking. This observational study conducted on a single visit will assess the phenotypic neurocognitive abnormalities of PKD patients with the LRRK2 mutation with the aim of identifying potential PD endpoints related to the LRRK2 mutation for future Phase I or II clinical trials of LRRK2 inhibitors.
Approximately 20 subjects with PKD bearing one of the known LRRK2 mutations will be investigated. Approximately 20 healthy subjects without the LRRK2 mutation who are matched with PKD patients will also be evaluated.
Healthy subjects are not expected to be taking medications for PKD. Subjects with PKD may continue their medications for PKD treatment throughout the study, Testing will take place within 30 days of screening, depending on the subject's availability.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LRRK2 Mutation and Parkinson's Disease: A Functional Neuroimaging and Behavioural Study Characterising the Neurocognitive Phenotype|
|Actual Study Start Date :||August 11, 2011|
|Actual Primary Completion Date :||January 12, 2015|
|Actual Study Completion Date :||January 12, 2015|
PKD Patients with LRRK2 mutation
Genetic: PKD Patients
Healthy Controls with no LRRK2 mutation
- Imaging (fMRI) [ Time Frame: Day 1 ]Action Selection, Tower of London, Shape manipulation, Emotional processing
- Cognition [ Time Frame: Day 1 ]Mini Mental State Examination (MMSE), Reward/punishment learning score, Task-set switching, Attentional set-shifting score, Spatial working memory score
- Olfactory [ Time Frame: Day 1 ]Sniffin' sticks
- Motor / Other [ Time Frame: Day 1 ]Unified Parkinson's Disease Rating Scale (UPDRS), Beck Depression Inventory (BDI), Parkinson's Disease Sleep Scale (PDSS), Nonmotor Symptoms Questionnaire, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease, Caffeine/Smoking Questionnaire
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 ClinicalTrials.gov identifier (NCT number): NCT01424475
|GSK Investigational Site|
|Cambridge, United Kingdom, CB2 2GG|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|