Trial Outcomes & Findings for Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression (NCT NCT00134784)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

142 participants

Primary outcome timeframe

40 weeks

Results posted on

2014-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo group	Levodopa 150mg/Day Levodopa 150mg/day, \[123I\]ß-CIT and SPECT imaging	Levodopa 300 mg/Day Levodopa 300mg/day, \[123I\]ß-CIT and SPECT imaging	Levodopa 600 mg/Day Levodopa 600/day, \[123I\]ß-CIT and SPECT imaging
Overall Study STARTED	29	38	37	38
Overall Study COMPLETED	27	36	35	37
Overall Study NOT COMPLETED	2	2	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo group	Levodopa 150mg/Day Levodopa 150mg/day, \[123I\]ß-CIT and SPECT imaging	Levodopa 300 mg/Day Levodopa 300mg/day, \[123I\]ß-CIT and SPECT imaging	Levodopa 600 mg/Day Levodopa 600/day, \[123I\]ß-CIT and SPECT imaging
Overall Study Withdrawal by Subject	2	2	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=29 Participants Subjects on placebo	Levodopa 150mg/Day n=38 Participants Subjects on 150mg/day of Levodopa	Levodopa 300 mg/Day n=37 Participants Subjects on 300 mg/day of Levodopa	Levodopa 600 mg/Day n=38 Participants Subjects on Levodopa 600 mg/day	Total n=142 Participants Total of all reporting groups
Age, Continuous Age of Subject in Years	63.9 years STANDARD_DEVIATION 10.5 • n=5 Participants	64.5 years STANDARD_DEVIATION 11.8 • n=7 Participants	63.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	62.3 years STANDARD_DEVIATION 9.8 • n=4 Participants	63.4 years STANDARD_DEVIATION 10.6 • n=21 Participants
Sex/Gender, Customized Female	7 participants n=5 Participants	15 participants n=7 Participants	8 participants n=5 Participants	11 participants n=4 Participants	41 participants n=21 Participants
Sex/Gender, Customized Male	22 participants n=5 Participants	23 participants n=7 Participants	29 participants n=5 Participants	27 participants n=4 Participants	101 participants n=21 Participants

PRIMARY outcome

Timeframe: 40 weeks

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	Placebo Group n=29 B-CIT Uptake Participants receiving placebo	Levodopa n=33 B-CIT Uptake Subjects on 150 mg/day of Levodopa	Levodopa 2 n=37 B-CIT Uptake Subjects on 300 mg/day of Levodopa	Levodopa 3 n=36 B-CIT Uptake Subjects on 600 mg/day of Levodopa
Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images	-2.6 percent change of B-CIT Uptake Standard Deviation 11.3	-4.7 percent change of B-CIT Uptake Standard Deviation 10.8	-3.7 percent change of B-CIT Uptake Standard Deviation 9.1	-6.9 percent change of B-CIT Uptake Standard Deviation 8.1

Adverse Events

I123BCIT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Institute for Neurodegenerative Disorders

Phone: 203 401 4300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place