CompletedNot Applicable

123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor

United States54 participantsStarted 2007-12

Plain-language summary

This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Currently, no radiopharmaceutical diagnostic imaging agent has been approved by the FDA in the U.S. for use in diagnosing Parkinson disease and related Parkinsonian syndromes. The diagnosis of Parkinsonian syndromes in the U.S. is based on clinical criteria only. The goal is to demonstrate that 123I-ALTROPANE® paired with SPECT imaging permits a more accurate early diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects must provide written informed consent prior to the initiation of any study related procedures;
. Subjects ≥ 40 years of age;
. Subjects with upper extremity tremor for \< 2 years duration.

Exclusion criteria

. Any clinically significant acute or unstable physical or psychological illness based on medical history or physical examination at Visit 1, as determined by the Principal Investigator;
. Any unexpected clinically significant abnormal laboratory or ECG results obtained at Visit 1 and as determined by the Principal Investigator;
. Any history of drug, narcotic, or alcohol abuse within 2 years prior to the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IVR {American Psychiatric Association, 1994 #2});

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To obtain a reference set of 123-I ALTROPANE® SPECT images.

Timeframe: Image obtained at Visit 2

Trial details

NCT IDNCT00596908

SponsorAlseres Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Upper Extremity Tremor trials