Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression

NCT00134784 | Completed Phase 2 Results

• 1 other identifier: Elldopa
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this project is to assess the change in dopamine transporter density in Parkinson's disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using \[123I\]ß-CIT SPECT (single photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of clinical disease state.

Conditions

Parkinson Disease

Keywords

parkinson; brain imaging

Outcome Measures

Primary Outcomes (1)

• Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images

  The use of SPECT to measure striatal dopamine-transporter density with the use of \[123I\]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.

  40 weeks

Study Arms (1)

Assess [123I]B-CIT SPECT imaging

EXPERIMENTAL

To assess\[123I\]B-CIT SPECT imaging in early Parkinson's disease subjects on placebo compared to early verses later Levodopa. Subjects on Levodopa 150mg/day, Levodopa 300 mg/day, and Levodopa 600 mg/day will be assessed.

Drug: [123I]B-CIT SPECT imaging

Interventions

[123I]B-CIT SPECT imaging DRUG

To assess \[123I\]B-CIT SPECT imaging

Also known as: [123I]B-CIT

Assess [123I]B-CIT SPECT imaging

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior participation in the study titled Dopamine Transporter Imaging Assessment of Parkinson's Disease Progression (DAMD17-99-1-9472) \[123I\] B-CIT and Spect in Vivo Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier Vs. Later Levodopa in Parkinson's Disease (ELLDOPA)\].

You may not qualify if:

• Inability to sign informed consent and participate in all study procedures.
• Mini mental status exam \< 25.
• Pregnancy

Sponsors & Collaborators

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

Related Publications (1)

• Fahn S, Oakes D, Shoulson I, Kieburtz K, Rudolph A, Lang A, Olanow CW, Tanner C, Marek K; Parkinson Study Group. Levodopa and the progression of Parkinson's disease. N Engl J Med. 2004 Dec 9;351(24):2498-508. doi: 10.1056/NEJMoa033447.

  PMID: 15590952 RESULT

Related Links

• Institute for Neurodegenerative Disorders

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Principal Investigator
• Organization: Institute for Neurodegenerative Disorders

kmarek@indd.org

203 401 4300

Study Officials

• Kenneth L Marek, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 25, 2005
• Study Start: April 1, 2000
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: August 8, 2014
• Results First Posted: August 8, 2014

Record last verified: 2014-07