Clinical trial NCT00354003: The Study of the Impact of Disclosing Imaging Study Information to Trial Participants
Official title: Impact of Disclosure of Dopamine Transporter Imaging Studies in PD Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinsonian Syndrome
Parkinson
Keywords: Parkinson
Imaging
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
First posted: 2006-07-19
Enrollment: 800
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Research participants who previously underwent ß-CIT imaging

Brief summary: The overall goal of the study is to evaluate how research participants in Parkinson Disease studies that include brain imaging with a dopamine transporter ligand choose to receive the imaging data and what is the impact of the imaging data information on the management of their symptoms.

Detailed description: Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.

Eligibility criteria: Inclusion Criteria:

* Previous participation in imaging study as described within the protocol

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Kenneth Marek, MD
role: PRINCIPAL_INVESTIGATOR
References:
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