NCT03555292

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 parkinson-disease

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
Last Updated

June 13, 2018

Status Verified

April 1, 2018

Enrollment Period

3.8 years

First QC Date

April 24, 2018

Last Update Submit

May 31, 2018

Conditions

Parkinson Disease

Keywords

11C-PIBParkinson's diseasedementiamild cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The cognitive scores in all patients

    0, 6month, 1year

Study Arms (5)

PD without dementia

EXPERIMENTAL

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

PD with MCI

EXPERIMENTAL

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

PD with dementia

EXPERIMENTAL

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

dementia with Lewy bodies

EXPERIMENTAL

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

healthy control

EXPERIMENTAL

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

Interventions

11C-PiBDRUG

11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans

PD with MCIPD with dementiaPD without dementiadementia with Lewy bodieshealthy control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Parkinson's disease and parkinsonian dementia syndromes
  • Males and females, ≥40 years old
  • 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.
  • They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.

You may not qualify if:

  • Females planning to bear a child recently or with childbearing potential
  • Renal function: serum creatinine \>3.0 mg/dL (270 μM/L)
  • Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
  • Known severe allergy or hypersensitivity to IV radiographic contrast.
  • Patients not able to enter the bore of the PET/CT scanner.
  • Inability to lie still for the entire imaging time because of cough, pain, etc.
  • Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
  • Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking Tian Tan Hospital, Capital Medical University

Beijing, China

RECRUITING

Tianjin Huanhu Hospital

Tianjin, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseDementiaCognitive Dysfunction

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Shuo Gao, MD

    Tianjin Medical University General Hospital

    STUDY DIRECTOR

Central Study Contacts

Li Cai, PhD

CONTACT

86-22-60362190XCL242004@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

June 13, 2018

Study Start

July 12, 2017

Primary Completion

May 12, 2021

Study Completion

October 12, 2021

Last Updated

June 13, 2018

Record last verified: 2018-04

Locations

CN(3)