Assessing Imaging as a Tool in Monitoring and Predicting the Progression of Parkinson Disease

NCT00404170 | Completed Phase 2

• 1 other identifier: Precept
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the utility of dopamine transporter imaging in monitoring and predicting the progression of Parkinson disease. This study will be performed in the PRECEPT cohort, an already existing cohort of 806 subjects recruited to participate in the study called, A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Early Parkinson's Disease - (PRECEPT), sponsored by Cephalon and Lundbeck and coordinated by the Parkinson Study Group. The imaging data from this long-term PRECEPT follow-up study will allow us to evaluate the long-term progression of DAT loss in PD, the long-term follow-up of SWEDD subjects, the relationship between long-term clinical and imaging PD outcomes, and the relationship between long-term imaging outcomes and genetic and biochemical biomarkers of PD progression.

Conditions

Parkinson Disease

Keywords

imaging; Parkinson; progression

Outcome Measures

Primary Outcomes (1)

• Assess progression of DAT loss during a 70 month interval

  70 months

Study Arms (1)

B-CIT and SPECT imaging

EXPERIMENTAL

To assess B-CIT injection and SPECT scanning. Optional ongoing B-CIT SPECT imaging scans at follow-up visits

Drug: B-CIT and SPECT imaging

Interventions

B-CIT and SPECT imaging DRUG

Optional ongoing B-CIT SPECT imaging scans at follow-up visits

B-CIT and SPECT imaging

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject was a participant in the PRECEPT clinical and imaging study
• Participant must be willing and able to comply with study procedures
• Participant must be willing and able to give informed consent.

You may not qualify if:

• The participant has a clinically significant clinical laboratory value and/or medical or psychiatric illness
• The participant has dementia (MMSE≤24)
• Pregnancy

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• United States Department of Defense: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Links

• Institute for Neurodegenerative Disorders

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Danna Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2006
• First Posted: November 27, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 5, 2022

Record last verified: 2019-04

Locations

US (1)