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

NCT02599753 | Completed Phase 2 DMC

• 1 other identifier: 101-4874A
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this protocol is to investigate the microstructural alterations and monoaminergic function in Parkinson's disease patients with impulse control disorders and cognitive impairment by multimodal MRI and 18F-DTBZ PET imaging.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• The difference of specific uptake ratio (SUR) of 18F- DTBZ between each diagnostic group

  The SUVRs of 18F-FP-(+)-DTBZ in ipsilateral caudate, anterior putamen, and bilateral nucleus accumbans were significantly lower in PDD group than those of PD group.

  4 years

Secondary Outcomes (1)

• The difference of eigenvalues obtained from diffusion tensor imaging (DTI) between each diagnostic group.

  4 years

Other Outcomes (1)

• The correlation between SURs of 18F-DTBZ and eigenvalues of DTI in each brain regions and the severity of motor or nonmotor symptoms.

  4 years

Study Arms (1)

18F-DTBZ for Parkinson's Disease

EXPERIMENTAL

The participants qualify for the study will return to the clinic at a later date and will have catheter(s) placed for i.v. administration of 18F- DTBZ for injection. The participants will receive a single i.v. bolus of 18F- DTBZ, followed by brain PET imaging of 10 minutes duration, approximately 80 minutes post-dose injection. Vital signs will be obtained prior to and immediately after the administration of 18F- DTBZ, and at the completion of the imaging session. Adverse events will be continuously monitored during the imaging session. The participants experience any adverse event will not be discharged until the event has resolved or stabilized.

Drug: 18-FDTBZ

Interventions

18-FDTBZ DRUG

During this study, participants will receive a single i.v. administration of approximately 370MBq (10 mCi) 18F- DTBZ immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV. The proposed dose for this study is based on the investigators' phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG (Lin 2010).

18F-DTBZ for Parkinson's Disease

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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).
• PD-ICD group: 35 subjects with a diagnosis of PD with ICD whom must:
• Male or female patients, age range 20\~80.

You may not qualify if:

• 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.
• Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
• History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
• History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
• 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.
• Any evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases (multiple system atrophy, progressive supranuclear palsy).
• History of allergy to radioligands that contain 18F isotope.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memory Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 1, 2015
• First Posted: November 9, 2015
• Study Start: August 1, 2015
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

TW (1)