The Assessment of the Diagnosis and Prognosis of Patients With Alzheimer Disease or Parkinson Disease With Cognitive Impairment by Using Diffusion MRI

NCT04434898 | Completed DMC

• 1 other identifier: 201701093B0
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis is that the differential extent of microstructural damages in the affected brain regions can be specific to the disease of interest and could reflect the clinical severity. Therefore, the investigator propose that whole brain parcellation of diffusion MRI can be used to improve diagnosis and prediction of clinical outcomes in Parkinson's Disease.

1. 1.A regression model between clinical severity and two year clinical outcomes and diffusion properties from multiple parcellated regions will be developed.
2. 2.Blind validation will be performed.

Conditions

Alzheimer Disease; Parkinson Disease

Keywords

magnetic resonance imaging; neurodegeneration disease; cognitive impairment; diagnosis; prognosis

Outcome Measures

Primary Outcomes (1)

• An objective image-based evidence for the diagnosis, differential diagnosis and prognosis of Parkinson's Disease

  The following will be measured for the diagnostic performance of diffusion MRI: 1. Regression between cognitive performance and baseline diffusion MRI using Pearson correlation 2. Leave one out cross validation

  end of the third year

Secondary Outcomes (5)

• Imaging

  end of the third year

• Imaging

  end of the third year

• Deep learning techniques

  end of the third year

• Prognosis

  end of the third year

• Prognosis

  end of the third year

Study Arms (3)

Ｍild cognitive impairment patients

The patients with mild cognitive impairment have a Clinical Dementia Rating score of 0.5. First, we will evaluate the correlation between diffusion MRI and the clinical severity and cognitive decline of patients. Second, we will evaluate if diffusion MRI can predict if these patients will develop Alzheimer's Disease and hence be involved in the third year of the study. Patients with mild cognitive impairment should meet the following criteria: 1. Between 50-80 years old 2. Right-handed 3. Clinical Dementia Rating score equal to 0.5 4. For patients who have a CDR score of 0.5, should be diagnosed by clinician's judgement of clinical information, daily living activities, and extent of neuropsychological disorders 5. Able to understand study requirements and give informed consent

Parkinson's Disease patients

This group consists of patients starting from 2012 to 2013 and includes 87 patients with typical Parkinson's Disease (PD), 15 patients with Progressive Supranuclear Paralysis (PSP), 15 patients with Multiple System Atrophy (MSA), and 15 patients with Cortico-Basal Degeneration (CBD). In differential diagnosis in the first year of the study, diffusion MRI will be used for a retrospective study.

Healthy volunteers

The healthy volunteers should meet the following criteria: 1. Between 50-80 years old 2. Right-handed 3. MMSE score greater than or equal to 26 4. Able to understand study requirements and give informed consent

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For each specific disease group, the following criteria should be meet: Healthy volunteers: MMSE score greater than or equal to 26. Mild cognitive impairment patients: a) Clinical Dementia Rating score equal to 0.5, b) Be diagnosed by clinician's judgement of clinical information. MSA patients should fulfill the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health criteria. PSP patients should fulfil the NINDS-SPSP and Litvan criteria. CBD patients should fulfil the NINDS-SPSP criteria, including limb stiffness or hypokinesia, dystonia, myoclonus, speaking disorders, and cortical sensory loss. The PD patients should be besides the age of onset, fulfil the NINDS-SPSP criteria.

You may qualify if:

• All subjects should meet the following criteria:
• Between 50-80 years old
• Right-handed
• Able to understand study requirements and give informed consent
• Agree to return for follow-up checks
• Able to suspend intake of medication for at least 12 hours

You may not qualify if:

• Cardiac pacemaker or defibrillator implantation Intracranial metal device implantation
• Other major systemic diseases, such as renal failure, heart failure, stroke, AMI/unstable angina, poorly controlled diabetes mellitus, poorly controlled hypertension
• Alcohol or drug abuse
• Moderate to severe dementia
• Severe movement disorders
• History of intracranial surgery including thalamotomy, pallidotomy, and/or deep brain stimulation
• Major physical or neuropsychiatric disorders
• Structural abnormalities that may cause dementia, such as cortical infarction, tumour, or subdural hematoma
• Besides medication for Parkinson's Disease, taking other medication with substances that can pass through the blood-brain barrier
• Besides medication for Parkinson's Disease, taking other medication for more than 10 years
• Treatments or concurrent illnesses other than Alzheimer's Disease that could interfere with cognitive function
• Meet the criteria for dementia (DSM-IV)
• Head trauma with loss of consciousness greater than 10 minutes
• Severe loss of sensation

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

ChangGung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Cognitive Dysfunction; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cognition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: June 17, 2020
• Study Start: October 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: September 30, 2020
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

TW (1)