Status:
TERMINATED
LRRK2 Mutation and Parkinson's Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pot...
Detailed Description
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 pot...
Eligibility Criteria
Inclusion
- Any Subject:
- Male or female, age: \>18 years.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Sufficiently fluent in English that they are able to understand written and spoken instructions in the opinion of the investigator.
Exclusion
- Subjects with previous or current drug or alcohol dependence within 2 years of screening.
- Subjects who are unable to tolerate study procedures including MRI, or who are unable to perform the study procedures (e.g. due to severe musculoskeletal disease).
- Use of other prescription or non-prescription centrally acting drugs, including herbal (eg khat) and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the procedures of Day 1, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Pregnant females as determined by positive serum or urine hCG test at screening.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Subject meets any of the MRI exclusion criteria.
- Subject is left-handed.
- PKD Patients:
- Inclusion Criteria:
- Diagnosis of Parkinson's disease according to the following criteria derived from the UKPD Society brain bank diagnostic criteria for PD (Hughes AJ et al., 1992):
- a) Bradykinesia must be present b) At least one of the following: muscular rigidity Resting tremor postural instability not caused by primary visual, vestibular, cerebellar or proprioceptive dysfunction c) Supportive prospective positive criteria for Parkinson's Disease (three of the following required for definite diagnosis): Resting tremor unilateral onset progressive disorder in first 5 years following onset, persistent asymmetry affecting side on which symptoms first appeared excellent response (70-100%) to levodopa in the clinical judgement of the investigator, based on the medical notes or during standard care d) None of the following clinical features which suggest a diagnosis other than Parkinson's disease: History of repeated strokes with stepwise symptom progression History of repeated head injury History of definite encephalitis Neuroleptic treatment at symptom onset Sustained remission Strictly unilateral features after 3 years Supranuclear gaze palsy Cerebellar signs In first five years following onset, early severe autonomic involvement such as orthostatic hypotension, impotence and bladder dysfunction Early (within 2 years on symptom onset) severe dementia with disturbed memory, language, praxis Babinski sign CT/MRI scan evidence of tumour or hydrocephalus Negative response to 1000mg of levodopa daily in divided doses.
- 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure
- Parkinson's disease in Hoehn \& Yahr criteria Stages I-III.
- Confirmed ascertainment as having the G2019S mutation in the LRRK2 gene.
Key Trial Info
Start Date :
August 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01424475
Start Date
August 11 2011
End Date
January 12 2015
Last Update
May 11 2017
Active Locations (1)
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1
GSK Investigational Site
Cambridge, United Kingdom, CB2 2GG