11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes

Safety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes

To evaluate the potential contribution of amyloid burden, as indexed by 11C-Pittsburgh compound B (PiB) retention, to the progression of cognitive impairments in patients with Parkinson's disease(PD).

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: 11C-PiB

Detailed Description

Study design:

Multi-center, Five-arm

Subjects:

Patients with PD without dementia; Patients with PD with mild cognitive impairment (MCI); Patients with PD with dementia; Patients with a dementia with Lewy bodies(DLB); Healthy person

Sample size:

200, including a PD without dementia group of 75 patients, a PD with MCI group of 30 patients, a PD with dementia group of 20 patients, a DLB group of 25 patients and a normal control group of 50 subjects.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Li Cai, PhD; Phone Number: 86-22-60362190; Email: XCL242004@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Tian Tan Hospital, Capital Medical University
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University General Hospital
  • Tianjin, China
    • Recruiting
    • Tianjin Huanhu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with Parkinson's disease and parkinsonian dementia syndromes
2. Males and females, ≥40 years old
3. The diagnosis of PD is established using the UK Parkinson's Disease Society Brain Bank Research Center Clinical diagnostic criteria. Criteria for PD-MCI and PD-dementia are consistent with those of the Movement Disorder Society. The DLB Consortium consensus criteria are used for DLB.
4. They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.

Exclusion Criteria:

1. Females planning to bear a child recently or with childbearing potential
2. Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
3. Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
4. Known severe allergy or hypersensitivity to IV radiographic contrast.
5. Patients not able to enter the bore of the PET/CT scanner.
6. Inability to lie still for the entire imaging time because of cough, pain, etc.
7. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

8. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD without dementia; 11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.	Drug: 11C-PiB; 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
Experimental: PD with MCI; 11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.	Drug: 11C-PiB; 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
Experimental: PD with dementia; 11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.	Drug: 11C-PiB; 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
Experimental: dementia with Lewy bodies; 11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.	Drug: 11C-PiB; 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
Experimental: healthy control; 11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.	Drug: 11C-PiB; 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amyloid burden range in all subjects	Outcome Measures: All patients underwent a 90-min dynamic 11C-PIB PET scan. 11C-PiB distribution volume ratio (DVR) will be estimated by using the PMOD software.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cognitive scores in all patients	Functional status is assessed by the Mini-Mental State Examination (MMSE). Parkinson disease with mild cognitive impairment：MMSE score 24-28; Parkinson disease with dementia: MMSE score ≤24; Parkinson disease with normal cognition: MMSE score >28.	0, 6month, 1year

Collaborators and Investigators

• Sponsor: Oriental Neurosurgery Evidence-Based-Study Team
• Investigators: Study Director: Shuo Gao, MD, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Anticipated): May 12, 2021
• Study Completion (Anticipated): October 12, 2021

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: dementia; mild cognitive impairment; Parkinson's disease; 11C-PIB
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dementia
• Other Study ID Numbers: CPBD2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No