Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2016
• Main ID: NCT02039024
• Date of registration: 15/01/2014
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET
• Scientific title: Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET
• Date of first enrolment: March 2012
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02039024
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Yi-Hsin Weng
• Affiliation: Chang Gung Memory Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1.10 healthy subjects : i. Male or female subjects, age range 20~80. ii. Subjects have no
known neurological or psychiatric disease. However, mild peripheral neuropathies, such as
entrapment syndrome or sciatica are allowed.iii. Subjects who provide a written informed
consent prior to study entry.

2.30 subjects with a diagnosis of PD : i. Male or female patients, age range 20~80. ii.
Patients should be fulfilled "UK Parkinson's Disease Society Brain Bank Clinical
Diagnostic Criteria" as "PD". (Appendix I).iii. Patients should not have any clinical
evidence of dementia or 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).

3.30 subjects with a diagnosis of PD with dementia : i. Male or female patients, age range
20~80.ii. Patients should be fulfilled the "Movement Disorders Society diagnostic criteria
of PDD as "possible" or "probable" PDD (Emre, 2006). (Appendix II) iii. 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).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).

4.20 subjects with a diagnosis of AD : i. Male or female patients, age range 20~80. ii.
Patients should be fulfilled the "DSM-IV-TR Diagnostic criteria for Alzheimer's Disease"
as AD. (Appendix III).iii. 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).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).

5.30 subjects with a diagnosis of PD with ICD : i. Male or female patients, age range
20~80. ii. 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).iii. 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).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).

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: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: 18F- DTBZ

Primary Outcome(s)

To compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET [Time Frame: 3 years]

Secondary ID(s)

100-4356A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Science Council, Taiwan