Parkinson DiseaseNCT01862744
Imaging Studies of Cognitive Impairment in Parkinson s Disease
An observational study of Parkinson Disease and Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Dementia
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2013to 3 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Neural Correlates of Cognitive Impairment in Parkinson Disease
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.
Read more
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.
Read the detailed description
Objectives:
The purpose of this protocol is to identify the neural correlates of cognitive impairment in
Parkinson disease (PD) using magnetic resonance imaging (MRI).
Study Population:
We will study 36 PD patients, defined by the UK Parkinson s Society Brain Bank diagnostic
criteria [1], consisting of 12 patients with cognitively normal PD (PD-CogNL), 12 with PD
with mild cognitive impairment (PD-MCI) [2], and 12 with PD with dementia (PDD) [3]. We
will also study 12 age- and gender-matched healthy volunteers (HVs) as controls.
Design:
This is an observational study and includes 3 PD patient subgroups (PD-CogNL, PD-MCI and PDD) and HVs group. Eligible participants will have one visit lasting 2- 4 days, ideally over 2 consecutive days. If the visit cannot be completed within that time frame, a second visit may be scheduled within 3 months to complete the assessments. They will have a clinical assessment, cognitive assessment, and MRI scans.
Outcome Measures and Hypothesis:
The primary outcome measure is the Mini-Mental State Examination (MMSE) score and
functional connectivity of cognitive networks, including default mode network, using restingstate
functional MRI (fMRI). We hypothesize that there is a group difference in functional
connectivity of cognitive networks between the PD patient subgroups and HVs. We also
hypothesize that there is a correlation between the MMSE score and functional connectivity
of the default mode network in PD patients.
Secondary outcome measures are fractional anisotropy (FA) values, functional
connectivity of the cognitive networks during working memory tasks, olfactory function
score and the functional connectivity of olfactory network, and scales of brain perfusion and
the functional connectivity of default mode network. We hypothesize that there: 1) is a group
difference in FA values between PD patient subgroups and the HVs; 2) are group differences
in functional connectivity of the cognitive networks during the working memory task
between PD patient subgroups and HVs; 3) is a correlation between olfactory function and
functional connectivity of the olfactory network in patients with PD-CogNL or PD-MCI; and
- are correlations between brain perfusion and the functional connectivity of the default mode network in PD patients.
- Conditions
- Parkinson Disease, Dementia
- Keywords
- Parkinson's Disease, MRI, Cognitive
- Medical subject headings
- Parkinson Disease, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity of cognitive networks using resting-state fMRI between patients with PD-CogNL, PD-MCI or PDD, and HVs.
Measured: ongoing
Correlate MMSE score with functional connectivity of the default mode network in PD patients.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start4 Apr 2013
- Primary completion30 Jan 2015
- Study completion3 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Codrin I Lungu, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862744
- Sponsor's protocol ID
- 130115
- Other IDs
- 13-N-0115
- Status last verified
- 3 Feb 2015
- First submitted
- 23 May 2013
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
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.
PubMed 1564476Litvan 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.
PubMed 22275317Emre 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.
PubMed 17542011
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Cognitive Impairment in Parkinson Disease
- ClinicalTrials.gov ID
- NCT01862744
- Acronym / sponsor ID
- 130115
- Conditions
- Parkinson Disease, Dementia
- Keywords
- Parkinson's Disease, MRI, Cognitive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 4 Apr 2013
- Primary completion
- 30 Jan 2015 (actual)
- Study completion
- 3 Feb 2015 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
The purpose of this protocol is to identify the neural correlates of cognitive impairment in
Parkinson disease (PD) using magnetic resonance imaging (MRI).
Study Population:
We will study 36 PD patients, defined by the UK Parkinson s Society Brain Bank diagnostic
criteria [1], consisting of 12 patients with cognitively normal PD (PD-CogNL), 12 with PD
with mild cognitive impairment (PD-MCI) [2], and 12 with PD with dementia (PDD) [3]. We
will also study 12 age- and gender-matched healthy volunteers (HVs) as controls.
Design:
This is an observational study and includes 3 PD patient subgroups (PD-CogNL, PD-MCI and PDD) and HVs group. Eligible participants will have one visit lasting 2- 4 days, ideally over 2 consecutive days. If the visit cannot be completed within that time frame, a second visit may be scheduled within 3 months to complete the assessments. They will have a clinical assessment, cognitive assessment, and MRI scans.
Outcome Measures and Hypothesis:
The primary outcome measure is the Mini-Mental State Examination (MMSE) score and
functional connectivity of cognitive networks, including default mode network, using restingstate
functional MRI (fMRI). We hypothesize that there is a group difference in functional
connectivity of cognitive networks between the PD patient subgroups and HVs. We also
hypothesize that there is a correlation between the MMSE score and functional connectivity
of the default mode network in PD patients.
Secondary outcome measures are fractional anisotropy (FA) values, functional
connectivity of the cognitive networks during working memory tasks, olfactory function
score and the functional connectivity of olfactory network, and scales of brain perfusion and
the functional connectivity of default mode network. We hypothesize that there: 1) is a group
difference in FA values between PD patient subgroups and the HVs; 2) are group differences
in functional connectivity of the cognitive networks during the working memory task
between PD patient subgroups and HVs; 3) is a correlation between olfactory function and
functional connectivity of the olfactory network in patients with PD-CogNL or PD-MCI; and
- are correlations between brain perfusion and the functional connectivity of the default mode network in PD patients.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 40 or older.
- Able to abstain from caffeine and alcohol for 24 hours before each visit.
- English is the first language.
- Right handed
- Established diagnosis of PD.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional connectivity of cognitive networks using resting-state fMRI between patients with PD-CogNL, PD-MCI or PDD, and HVs.
Time frame: ongoing
Correlate MMSE score with functional connectivity of the default mode network in PD patients.
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 1564476Hughes 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.
- Background: PubMed 22275317Litvan 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.
- Background: PubMed 17542011Emre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Codrin I Lungu, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity of cognitive networks using resting-state fMRI between patients with PD-CogNL, PD-MCI or PDD, and HVs. (time frame: ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862744, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.