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Official Study Title: Recruitment and Sample Collection for Antecedent Biomarker Discovery in Parkinson’s Disease
Sponsor: The Department of Defense
Clinicaltrials.gov ID:
Study ID:

Summary

The main purpose of the study is to learn about changes in genes and gene  GeneUnits of heredity that are made of DNA and contained in every cell. They produce proteins that control biological development and function. products in people with rapid eye movement (REM) sleep behavior disorder and in Parkinson’s disease (PD) before and after starting medications. The second purpose is to learn whether other clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. tests can predict which individuals with REM sleep behavior disorder will go on to develop PD.

The study will enroll about 50 REM sleep behavior disorder participants, 25 early Parkinson’s disease participants, and 25 control participants who do not have PD or REM sleep behavior disorder.  Researchers will collect detailed clinical data on these participants and will collect, process, and archive peripheral blood samples for future DNA, RNA, proteomic and metabolomic studies.

As part of this study, researchers will collect and store blood samples from you that will allow them to study differences in patterns of genes and gene products. They ask permission for your samples to be stored in a sample bank at Georgetown University for use in future research studies related to PD or other related brain diseases. The blood tube containing participants’ samples will be labeled using only a unique code and site number. Blood samples will never be labeled with participants’ names or other identifying information. Samples will only be used by qualified researchers, located at Georgetown University or other universities. Each proposed study is reviewed by a group of scientists. Every project is also reviewed by a group that protects the rights of people who take part in the study. Once participants sign the consent form, they will not be asked again about participation in the specific studies using their stored samples. The researchers plan on keeping blood samples indefinitely. If a participant decides now that samples can be kept for research, they can change their mind at any time.

Study Phase

Not Applicable
What is a study phase?

Time Commitment

• Less than six months
• Screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. phone call of about 30 minutes, followed by a two hour clinic visit prior to starting any antiparkinson medication and then a one hour clinic visit eight weeks after starting antiparkinson medication.

Eligibility

• Minimum Age: 21
• Maximum Age: 85
• Gender(s) Accepted: Either
• Study is enrolling non-PD participants

Inclusion Criteria

Inclusion criteria for all participants:

• English speaking.
• No prior exposure to antiparkinson medications.

Inclusion criteria for REM sleep behavior disorder (RSBD) participants:

• Age 21 to 85 years.  The mean age at onset of PD is 63 years and the researchers would like to identify preclinical participants close to the onset of PD so that we will have an opportunity to detect disease onset in a substantial number of participants.  The researchers also want to enroll participants at an age not too advanced so that there is a good chance of completing up to five years of prospective observation.
• Diagnosed by a sleep medicine specialist within the past two years with RSBD.
• Use of a serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, mirtazapine or venlafaxine in the 12 weeks prior to diagnosis is an exclusion for cases with RSBD since these medications might precipitate this condition or at least REM sleep without atonia.  People with untreated sleep apnea will also be excluded since this condition may trigger behaviors out of REM sleep;  participants with treated sleep apnea can be included.
• The researchers are particularly interested in participants with later-life onset of these suspected premotor conditions since there is probably a greater likelihood of them reflecting an underlying neurodegenerative condition, namely PD.  They have chosen an expanded age range due to low enrollment, but still expect most of participants to be above the age of 40. 

Inclusion criteria for PD participants:

• Diagnosis of PD by a movement disorders expert.
• No previous exposure to any medication used to treat PD.
• No previous exposure to any drug known to induce parkinsonism.

Inclusion criteria for healthy controls:

• No previous diagnosis of any neurodegenerative disorder.

Exclusion Criteria

• Presence of dementia.  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality.
• Known history of stroke or head trauma with any residual symptoms.
• Use of any medications in the past five years which might induce parkinsonism, including neuroleptic antipsychotics, atypical antipsychotics, reserpine, tetrabenazine and metoclopramide.
• Use of any antiparkinsonian medication (including, for example, people treated with a dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. agonist for RSBD or periodic limb movements of sleep).
• Presence of any serious medical illness associated with a life expectancy of five years or less.
• Conditions that might be associated with cardiac dysautonomia (disease of autonomic nervous system)  Autonomic Nervous SystemControls automatic functions, such as heartbeat, digestion, salivation, and blood pressure. , including major coronary artery disease, major congestive heart disease, diabetes requiring more than dietary therapy,  TherapyAnother word for “treatment”. clinically significant peripheral polyneuropathy, known clinically significant autonomic dysfunction other than constipation.
• Chronic abnormalities in complete blood count outside of normal ranges.
• Seizure disorder, including epilepsy.
• Anemia requiring therapy and/or transfusion.
• Chronic myeloproliferative disorders (e.g., polycythemia vera, essential throbocythemia, leukemia).
• Waldenströms’s macroglobulinemia.
• Idiopathic/  IdiopathicOf, relating to, or designating a disease having no known cause. thromocytopenic pupura.
• Any malignancy (<6 months).
• Recent/current history (< I month) usage of anticonvulsants, neuroleptics, highly active antiretroviral therapy (HAART), antipsychotics, antiemetics.

Enrollment

Expected Enrollment: 100 (US)
Date Enrollment Began: Jan 2011
Date Enrollment Ends: Feb 2012
Last Updated Date: Oct 05 2011
Trial Post Date: Oct 05 2011
Website:

Primary Contacts and Locations

New York

• Heather-Rae Kennedy
  University of Rochester Medical Center Strong Sleep Disorders Center
  heather_kennedy@urmc.rochester.edu
  Phone: (585) 273-2571
  Rochester, NY 14618
  USA