Parkinsonian SyndromeNCT00354003
The Study of the Impact of Disclosing Imaging Study Information to Trial Participants
An observational study of Parkinsonian Syndrome and Parkinson, run by Institute for Neurodegenerative Disorders at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinsonian Syndrome, Parkinson
- What is being tested?
- A series of questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Research participants who previously underwent ß-CIT imaging
Who may be able to join
- Previous participation in imaging study as described within the protocol
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
About this study
Official title: Impact of Disclosure of Dopamine Transporter Imaging Studies in PD Clinical Trials
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.
Read the 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.
- Conditions
- Parkinsonian Syndrome, Parkinson
- Being tested
- A series of questionnaires
- Keywords
- Parkinson, Imaging
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A series of questionnairesBehavioural
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startJul 2006
- Primary completion27 Jun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Parkinsonian SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Marek, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354003
- Sponsor's protocol ID
- IMAG-DIS 01
- Status last verified
- Apr 2019
- First submitted
- 17 Jul 2006
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Asenbaum S, Brucke T, Pirker W, Podreka I, Angelberger P, Wenger S, Wober C, Muller C, Deecke L. Imaging of dopamine transporters with iodine-123-beta-CIT and SPECT in Parkinson's disease. J Nucl Med. 1997 Jan;38(1):1-6.
PubMed 8998140Mozley PD, Schneider JS, Acton PD, Plossl K, Stern MB, Siderowf A, Leopold NA, Li PY, Alavi A, Kung HF. Binding of [99mTc]TRODAT-1 to dopamine transporters in patients with Parkinson's disease and in healthy volunteers. J Nucl Med. 2000 Apr;41(4):584-9.
PubMed 10768556Booij J, Habraken JB, Bergmans P, Tissingh G, Winogrodzka A, Wolters EC, Janssen AG, Stoof JC, van Royen EA. Imaging of dopamine transporters with iodine-123-FP-CIT SPECT in healthy controls and patients with Parkinson's disease. J Nucl Med. 1998 Nov;39(11):1879-84.
PubMed 9829575Innis RB, Seibyl JP, Scanley BE, Laruelle M, Abi-Dargham A, Wallace E, Baldwin RM, Zea-Ponce Y, Zoghbi S, Wang S, et al. Single photon emission computed tomographic imaging demonstrates loss of striatal dopamine transporters in Parkinson disease. Proc Natl Acad Sci U S A. 1993 Dec 15;90(24):11965-9. doi: 10.1073/pnas.90.24.11965.
PubMed 8265656Kaufman MJ, Madras BK. Severe depletion of cocaine recognition sites associated with the dopamine transporter in Parkinson's-diseased striatum. Synapse. 1991 Sep;9(1):43-9. doi: 10.1002/syn.890090107.
PubMed 1796351Niznik HB, Fogel EF, Fassos FF, Seeman P. The dopamine transporter is absent in parkinsonian putamen and reduced in the caudate nucleus. J Neurochem. 1991 Jan;56(1):192-8. doi: 10.1111/j.1471-4159.1991.tb02580.x.
PubMed 1987318Wilson JM, Levey AI, Rajput A, Ang L, Guttman M, Shannak K, Niznik HB, Hornykiewicz O, Pifl C, Kish SJ. Differential changes in neurochemical markers of striatal dopamine nerve terminals in idiopathic Parkinson's disease. Neurology. 1996 Sep;47(3):718-26. doi: 10.1212/wnl.47.3.718.
PubMed 8797470Huang WS, Lin SZ, Lin JC, Wey SP, Ting G, Liu RS. Evaluation of early-stage Parkinson's disease with 99mTc-TRODAT-1 imaging. J Nucl Med. 2001 Sep;42(9):1303-8.
PubMed 11535717Booij J, Tissingh G, Boer GJ, Speelman JD, Stoof JC, Janssen AG, Wolters EC, van Royen EA. [123I]FP-CIT SPECT shows a pronounced decline of striatal dopamine transporter labelling in early and advanced Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Feb;62(2):133-40. doi: 10.1136/jnnp.62.2.133.
PubMed 9048712Fischman AJ, Bonab AA, Babich JW, Palmer EP, Alpert NM, Elmaleh DR, Callahan RJ, Barrow SA, Graham W, Meltzer PC, Hanson RN, Madras BK. Rapid detection of Parkinson's disease by SPECT with altropane: a selective ligand for dopamine transporters. Synapse. 1998 Jun;29(2):128-41. doi: 10.1002/(SICI)1098-2396(199806)29:23.0.CO;2-9.
PubMed 9593103Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, van Dyck C, et al. Decreased single-photon emission computed tomographic [123I]beta-CIT striatal uptake correlates with symptom severity in Parkinson's disease. Ann Neurol. 1995 Oct;38(4):589-98. doi: 10.1002/ana.410380407.
PubMed 7574455Volkow ND, Fowler JS, Wang GJ, Logan J, Schlyer D, MacGregor R, Hitzemann R, Wolf AP. Decreased dopamine transporters with age in health human subjects. Ann Neurol. 1994 Aug;36(2):237-9. doi: 10.1002/ana.410360218.
PubMed 8053661van Dyck CH, Seibyl JP, Malison RT, Laruelle M, Zoghbi SS, Baldwin RM, Innis RB. Age-related decline in dopamine transporters: analysis of striatal subregions, nonlinear effects, and hemispheric asymmetries. Am J Geriatr Psychiatry. 2002 Jan-Feb;10(1):36-43.
PubMed 11790633Khan NL, Brooks DJ, Pavese N, Sweeney MG, Wood NW, Lees AJ, Piccini P. Progression of nigrostriatal dysfunction in a parkin kindred: an [18F]dopa PET and clinical study. Brain. 2002 Oct;125(Pt 10):2248-56. doi: 10.1093/brain/awf237.
PubMed 12244082Dekker M, Bonifati V, van Swieten J, Leenders N, Galjaard RJ, Snijders P, Horstink M, Heutink P, Oostra B, van Duijn C. Clinical features and neuroimaging of PARK7-linked parkinsonism. Mov Disord. 2003 Jul;18(7):751-7. doi: 10.1002/mds.10422.
PubMed 12815653
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Disclosure of Dopamine Transporter Imaging Studies in PD Clinical Trials
- ClinicalTrials.gov ID
- NCT00354003
- Acronym / sponsor ID
- IMAG-DIS 01
- Conditions
- Parkinsonian Syndrome, Parkinson
- Keywords
- Parkinson, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- 27 Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 19 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Research participants who previously underwent ß-CIT imaging
Key inclusion criteria (1 listed)
- Previous participation in imaging study as described within the protocol
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A series of questionnairesResearch 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. | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Background: PubMed 8998140Asenbaum S, Brucke T, Pirker W, Podreka I, Angelberger P, Wenger S, Wober C, Muller C, Deecke L. Imaging of dopamine transporters with iodine-123-beta-CIT and SPECT in Parkinson's disease. J Nucl Med. 1997 Jan;38(1):1-6.
- Background: PubMed 10768556Mozley PD, Schneider JS, Acton PD, Plossl K, Stern MB, Siderowf A, Leopold NA, Li PY, Alavi A, Kung HF. Binding of [99mTc]TRODAT-1 to dopamine transporters in patients with Parkinson's disease and in healthy volunteers. J Nucl Med. 2000 Apr;41(4):584-9.
- Background: PubMed 9829575Booij J, Habraken JB, Bergmans P, Tissingh G, Winogrodzka A, Wolters EC, Janssen AG, Stoof JC, van Royen EA. Imaging of dopamine transporters with iodine-123-FP-CIT SPECT in healthy controls and patients with Parkinson's disease. J Nucl Med. 1998 Nov;39(11):1879-84.
- Background: PubMed 8265656Innis RB, Seibyl JP, Scanley BE, Laruelle M, Abi-Dargham A, Wallace E, Baldwin RM, Zea-Ponce Y, Zoghbi S, Wang S, et al. Single photon emission computed tomographic imaging demonstrates loss of striatal dopamine transporters in Parkinson disease. Proc Natl Acad Sci U S A. 1993 Dec 15;90(24):11965-9. doi: 10.1073/pnas.90.24.11965.
- Background: PubMed 1796351Kaufman MJ, Madras BK. Severe depletion of cocaine recognition sites associated with the dopamine transporter in Parkinson's-diseased striatum. Synapse. 1991 Sep;9(1):43-9. doi: 10.1002/syn.890090107.
- Background: PubMed 1987318Niznik HB, Fogel EF, Fassos FF, Seeman P. The dopamine transporter is absent in parkinsonian putamen and reduced in the caudate nucleus. J Neurochem. 1991 Jan;56(1):192-8. doi: 10.1111/j.1471-4159.1991.tb02580.x.
- Background: PubMed 8797470Wilson JM, Levey AI, Rajput A, Ang L, Guttman M, Shannak K, Niznik HB, Hornykiewicz O, Pifl C, Kish SJ. Differential changes in neurochemical markers of striatal dopamine nerve terminals in idiopathic Parkinson's disease. Neurology. 1996 Sep;47(3):718-26. doi: 10.1212/wnl.47.3.718.
- Background: PubMed 11535717Huang WS, Lin SZ, Lin JC, Wey SP, Ting G, Liu RS. Evaluation of early-stage Parkinson's disease with 99mTc-TRODAT-1 imaging. J Nucl Med. 2001 Sep;42(9):1303-8.
- Background: PubMed 9048712Booij J, Tissingh G, Boer GJ, Speelman JD, Stoof JC, Janssen AG, Wolters EC, van Royen EA. [123I]FP-CIT SPECT shows a pronounced decline of striatal dopamine transporter labelling in early and advanced Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Feb;62(2):133-40. doi: 10.1136/jnnp.62.2.133.
- Background: PubMed 9593103Fischman AJ, Bonab AA, Babich JW, Palmer EP, Alpert NM, Elmaleh DR, Callahan RJ, Barrow SA, Graham W, Meltzer PC, Hanson RN, Madras BK. Rapid detection of Parkinson's disease by SPECT with altropane: a selective ligand for dopamine transporters. Synapse. 1998 Jun;29(2):128-41. doi: 10.1002/(SICI)1098-2396(199806)29:23.0.CO;2-9.
- Background: PubMed 7574455Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, van Dyck C, et al. Decreased single-photon emission computed tomographic [123I]beta-CIT striatal uptake correlates with symptom severity in Parkinson's disease. Ann Neurol. 1995 Oct;38(4):589-98. doi: 10.1002/ana.410380407.
- Background: PubMed 8053661Volkow ND, Fowler JS, Wang GJ, Logan J, Schlyer D, MacGregor R, Hitzemann R, Wolf AP. Decreased dopamine transporters with age in health human subjects. Ann Neurol. 1994 Aug;36(2):237-9. doi: 10.1002/ana.410360218.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Marek, MD principal investigator
Institute for Neurodegenerative Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsonian Syndrome and Parkinson, run by Institute for Neurodegenerative Disorders at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00354003, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.