Imaging Studies of Cognitive Impairment in Parkinson s Disease

NCT01862744 | Completed

• 2 other identifiers: 13011513-N-0115
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Dementia

Keywords

Parkinson's Disease; MRI; Cognitive

Outcome Measures

Primary Outcomes (2)

• Functional connectivity of cognitive networks using resting-state fMRI between patients with PD-CogNL, PD-MCI or PDD, and HVs.

  ongoing

• Correlate MMSE score with functional connectivity of the default mode network in PD patients.

  ongoing

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all subjects:
• Age 40 or older.
• Able to abstain from caffeine and alcohol for 24 hours before each visit.
• English is the first language.
• Right handed
• For PD cohort:
• Established diagnosis of PD.
• History compatible with diagnosis of PD
• Present with at least 3 of the following features: bradykinesia, resting tremor, cogwheel rigidity or postural reflex impairment
• One of the 3 clinical features is either bradykinesia or resting tremor
• Currently taking or history of taking dopaminergic therapy with symptomatic response.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.

  PMID: 1564476 BACKGROUND

• Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.

  PMID: 22275317 BACKGROUND

• Emre M, Aarsland D, Brown R, Burn DJ, Duyckaerts C, Mizuno Y, Broe GA, Cummings J, Dickson DW, Gauthier S, Goldman J, Goetz C, Korczyn A, Lees A, Levy R, Litvan I, McKeith I, Olanow W, Poewe W, Quinn N, Sampaio C, Tolosa E, Dubois B. Clinical diagnostic criteria for dementia associated with Parkinson's disease. Mov Disord. 2007 Sep 15;22(12):1689-707; quiz 1837. doi: 10.1002/mds.21507.

  PMID: 17542011 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Codrin I Lungu, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 24, 2013
• Study Start: April 4, 2013
• Primary Completion: January 30, 2015
• Study Completion: February 3, 2015
• Last Updated: December 12, 2019

Record last verified: 2015-02-03

Locations

US (1)