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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this protocol is to investigate the monoaminergic (dopamine、serotonin、and norepinephrine ) nervous system and amyloid deposition in Parkinson's disease patients with non-motor symptoms (focus on impulse control disorders and dementia) by novel 18F-DTBZ and Florbetapir F-18 PET imaging.

This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group.

Investigators will also analyze monoaminergic function by18F- DTBZ PET in PDI group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: National Science Council, Taiwan

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.