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Imaging Studies of Cognitive Impairment in Parkinson s Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01862744
First received: May 23, 2013
Last updated: March 26, 2014
Last verified: February 2014
  Purpose

Background:

- Parkinson's disease causes slow movements, stiffness, and tremor. It can get worse over time, and in some cases can lead to dementia. Researchers are interested in how dementia affects the brain in people with Parkinson's disease. They will study both people with Parkinson s disease and healthy volunteers. They will give tests of thinking and memory, and look at brain activity using imaging studies. This may provide more information on what parts of the brain are not working well in people who have dementia related to Parkinson's disease.

Objectives:

- To use imaging studies to see what parts of the brain do not work well in people with dementia caused by Parkinson's disease.

Eligibility:

  • Individuals at least 40 years of age who have Parkinson s disease.
  • Healthy volunteers at least 40 years of age.

Design:

  • Participants will be screened with a medical history and physical exam.
  • This study requires two outpatient visits over 2 days.
  • Participants will have tests of thinking, memory, and concentration. They will answer questions and fill out questionnaires. The tests will also look at how quickly they can move and handle small objects. The tests will take about 3 hours.
  • Participants will have magnetic resonance imaging to study the brain. Functional MRI (fMRI) can show what parts of the brain are used when performing a task. Participants will respond to images on a computer screen during fMRI.
  • Treatment will not be provided as part of this study.

Condition
Parkinson Disease
Dementia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neural Correlates of Cognitive Impairment in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Functional connectivity of cognitive networks using resting-state fMRI between patients with PD-CogNL, PD-MCI or PDD, and HVs. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Correlate MMSE score with functional connectivity of the default mode network in PD patients. [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

For all subjects:

  1. Age 40 or older.
  2. Able to abstain from caffeine and alcohol for 24 hours before each visit.
  3. English is the first language.
  4. Right handed

For PD cohort:

  1. Established diagnosis of PD.
  2. History compatible with diagnosis of PD
  3. Present with at least 3 of the following features: bradykinesia, resting tremor, cogwheel rigidity or postural reflex impairment
  4. One of the 3 clinical features is either bradykinesia or resting tremor
  5. Currently taking or history of taking dopaminergic therapy with symptomatic response.
  6. Is able to give informed consent or, if there is evidence of cognitive decline, able to give assent and able to appoint a durable power of attorney (DPA) who can give informed consent.

EXCLUSION CRITERIA for all subjects:

  • Use of illegal drugs within the past 6 months.
  • More than 7 alcoholic drinks a week for females or 14 alcoholic drinks a week for males.
  • History of a neurologic disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, a movement disorder, epilepsy or a history of seizures, except PD for PD patients.
  • History of any head injury with loss of consciousness.
  • Pregnancy or positive pregnancy test before the research procedure due to the risks associated with MRI scans.
  • Inability to lie flat on the back for up to 2 hours.
  • Claustrophobia or a feeling of discomfort from being in small, enclosed spaces of enough severity to prevent MRI scanning.
  • Surgically or traumatically implanted metallic foreign bodies, such as pacemakers, implanted medical pumps, implanted hearing aids, metal plates in the skull or metal implants in the skull or eyes (other than dental fillings) that may be physically hazardous during an MRI, or might distort the images.
  • Ablative surgery or implanted electrodes and generator for deep brain stimulation
  • Use of the following medications or substances within 6 months of getting MRI scan: e.g., Cocaine, amphetamines, methylphenidate, ephedrine, phentermine, buproprion, fentanyl, ketamine, and phencyclidine. Prescribed medication for common conditions, such as allergy or cold, will not be exclusionary. Prescribed medication for PD will not be exclusionary for PD patient.
  • Have uncontrolled head movements that may impair image data collection (for PD patients).
  • Subjects with MMSE< 26 for HVs.
  • Have clinically relevant focal neurological findings on exam that suggest cerebral pathology other than that associated with PD for PD patients.
  • Any abnormal or focal finding on neurological exam for HVs.
  • Abnormal findings in clinical MRI.
  • PD patients with Beck Depression Inventory (BDI)-II > 31 will be excluded, because severe or extreme depression may confound with cognitive function.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862744

Contacts
Contact: Beverly A McElroy, R.N. (301) 402-4479 mcelroyb@ninds.nih.gov
Contact: Codrin I Lungu, M.D. (301) 402-0976 lunguci@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Codrin I Lungu, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01862744     History of Changes
Other Study ID Numbers: 130115, 13-N-0115
Study First Received: May 23, 2013
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Parkinson's Disease
MRI
Cognitive

Additional relevant MeSH terms:
Parkinson Disease
Cognition Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 25, 2014