Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02599753
• Date of registration: 01/11/2015
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients
• Scientific title: Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients With Neuropsychiatric Disorders by Multimodal Neuroimaging
• Date of first enrolment: August 2015
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02599753
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Taiwan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. PD group: 35 subjects with a diagnosis of PD whom must:

- Male or female patients, age range 20~80.

- Patients should not have any clinical evidence of cognitive impairment or ICD.

- Patients who provide a written informed consent prior to study entry. If the
patient is incapable of informed consent, the caregiver may consent on behalf of
the patient (the patient must still confirm assent).

2. PD-MCI group: 35 subjects with a diagnosis of PD with mild cognitive impairment whom
must:

- Male or female patients, age range 20~80.

- Patients should be fulfilled the"Diagnostic Criteria for Mild Cognitive
Impairment in Parkinson's Disease: Movement Disorder Society Task Force
Guidelines" as PD-MCI. (Litvan, 2012; Appendix II).

- Patients should not have any clinical evidence of ICD.

- Patients who provide a written informed consent prior to study entry. If the
patient is incapable of informed consent, the caregiver may consent on behalf of
the patient (the patient must still confirm assent).

3. PDD group: 35 subjects with a diagnosis of PD with dementia whom must:

- Male or female patients, age range 20~80.

- Patients should be fulfilled the "Movement Disorders Society diagnostic criteria
of PDD as "possible" or "probable" PDD (Emre, 2006). (Appendix III)

- Patients should not have any clinical evidence of ICD. iv.Patients who provide a
written informed consent prior to study entry. If the patient is incapable of
informed consent, the caregiver may consent on behalf of the patient (the patient
must still confirm assent).

4. PD-ICD group: 35 subjects with a diagnosis of PD with ICD whom must:

- Male or female patients, age range 20~80.

- Patients should be fulfilled one of the diagnostic criteria or definition in
these ICDs: pathological gambling, hypersexuality, compulsive shopping,
compulsive eating, punding, and compulsive medication use (Voon, 2009). (Appendix
IV).

- Patients should not have any clinical evidence of dementia or cognitive
impairment.

- Patients who provide a written informed consent prior to study entry. If the
patient is incapable of informed consent, the caregiver may consent on behalf of
the patient (the patient must still confirm assent).

Exclusion Criteria:

1. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at
screening or at any date during the study according to the PI discretion) or current
breast feeding.

2. Any subject who has a clinically significant abnormal laboratory values, and/or
clinically significant or unstable medical or psychiatric illness.

3. History of drug or alcohol abuse within the last year, or prior prolonged history of
abuse.

4. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep
brain stimulation.

5. Any documented abnormality in the brain by CT or MRI of brain, which might contribute
to the motor function, such as hydrocephalus, multiple infarction and
encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white
matter changes will be allowed.

6. Any evidence of secondary parkinsonism (multiple infarcts, intoxication, and
hydrocephalus, etc) or other neurodegenerative diseases (multiple system atrophy,
progressive supranuclear palsy).

7. History of allergy to radioligands that contain 18F isotope.



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: 18-FDTBZ

Primary Outcome(s)

The difference of specific uptake ratio (SUR) of 18F- DTBZ between each diagnostic group [Time Frame: 4 years]

Secondary Outcome(s)

The difference of eigenvalues obtained from diffusion tensor imaging (DTI) between each diagnostic group. [Time Frame: 4 years]

Secondary ID(s)

101-4874A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors