NCT05636852 is a Phase 2 clinical trial of Altropane (123I) Injection in Parkinson Disease, sponsored by GE Healthcare.

Who is sponsoring NCT05636852?

NCT05636852 is sponsored by GE Healthcare.

What drugs are being tested in NCT05636852?

Interventions in NCT05636852: Altropane (123I) Injection.

What condition does NCT05636852 study?

NCT05636852 studies Parkinson Disease, Movement Disorders.

Is NCT05636852 still recruiting?

NCT05636852 is currently terminated. Last updated 15 July 2025.

Are results published for NCT05636852?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-15 · How we verify

NCT05636852

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Altropane Dose for Imaging Patients With Suspected Parkinson's Disease

Terminated Phase 2 Results posted Last updated 15 July 2025

What this trial tests

Phase 2 trial testing Altropane (123I) Injection in Parkinson Disease in 15 participants. Terminated before completion.

Timeline

24 April 2023

Primary endpoint
8 June 2024

8 June 2024

Quick facts

Lead sponsor	GE Healthcare
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	15
Start date	24 April 2023
Primary completion	8 June 2024
Estimated completion	8 June 2024
Sites	4 locations across United States

Drugs / interventions tested

Altropane (123I) Injection — full drug profile →

Conditions studied

Parkinson Disease — all drugs for Parkinson Disease →
Movement Disorders — all drugs for Movement Disorders →

Sponsor

GE Healthcare — full company profile →

Who can join

18 and older, any sex, with Parkinson Disease or Movement Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers Primary · Day 1, up to 30 minutes

Assessment of the Altropane SPECT images was performed by 5 independent expert blinded readers to determine striatal uptake, reported as a forced choice of either normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced). Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers).

Reader 1

Group	Value	95% CI
Part 1: Altropane (123I) Injection	60

Reader 2

Group	Value	95% CI
Part 1: Altropane (123I) Injection	80

Reader 3

Group	Value	95% CI
Part 1: Altropane (123I) Injection	90

Reader 4

Group	Value	95% CI
Part 1: Altropane (123I) Injection	70

Reader 5

Group	Value	95% CI
Part 1: Altropane (123I) Injection	80

Majority Readers

Group	Value	95% CI
Part 1: Altropane (123I) Injection	80

Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization) Secondary · Day 1, up to 30 minutes

Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers evaluated their confidence in striatal visualization, rating it as high, medium, or low. Majority classification was determined from the majority interpretati

Reader 1 : High

Group	Value	95% CI
Part 1: Altropane (123I) Injection	40

Reader 1 : Medium

Group	Value	95% CI
Part 1: Altropane (123I) Injection	40

Reader 1 : Low

Group	Value	95% CI
Part 1: Altropane (123I) Injection	20

Reader 2 : High

Group	Value	95% CI
Part 1: Altropane (123I) Injection	80

Reader 2 : Medium

Group	Value	95% CI
Part 1: Altropane (123I) Injection	20

Reader 2 : Low

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Reader 3 : High

Group	Value	95% CI
Part 1: Altropane (123I) Injection	70

Reader 3 : Medium

Group	Value	95% CI
Part 1: Altropane (123I) Injection	30

Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality) Secondary · Day 1, up to 30 minutes

Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers assessed image quality as excellent, good, fair, poor, or unevaluable. Majority classification was determined from the majority interpretation of the 5 expert

Reader 1 : Excellent

Group	Value	95% CI
Part 1: Altropane (123I) Injection	90

Reader 1 : Good

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Reader 1 : Fair

Group	Value	95% CI
Part 1: Altropane (123I) Injection	10

Reader 1 : Unevaluable

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Reader 2 : Excellent

Group	Value	95% CI
Part 1: Altropane (123I) Injection	70

Reader 2 : Good

Group	Value	95% CI
Part 1: Altropane (123I) Injection	30

Reader 2 : Fair

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Reader 2 : Unevaluable

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Inter-Reader Agreement on Percentage of Participants With Normal Images Secondary · Day 1, up to 30 minutes

Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each subject's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Percentage of participants with inter-reader agreement on striatal visualization classification for whom 5, 4, and 3 readers, respectively, were in agreement on the parti

5 Readers in Agreement

Group	Value	95% CI
Part 1: Altropane (123I) Injection	70

4 Readers in Agreement

Group	Value	95% CI
Part 1: Altropane (123I) Injection	20

3 Readers in Agreement

Group	Value	95% CI
Part 1: Altropane (123I) Injection	10

Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) Secondary · From administration of Altropane until 24 hours post dose

An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as AEs that started or worsened between the start of pharmaceutical product administration and the end of the follow-up period.

Group	Value	95% CI
Part 1: Altropane (123I) Injection	23.1

Percentage of Participants With Adverse Drug Reaction (ADR) Secondary · From administration of Altropane until 24 hours post dose

ADR is an AE that is caused by the investigational medicinal product.

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs Secondary · From administration of Altropane until 24 hours post dose

Percentage of participants with clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature). Normal limits of vital signs are: 1. Systolic BP (mmHg) - low: 85 and High: 139; Diastolic BP (mmHg) - low: 60 and High: 89. 2. Heart rate (bpm) - low: 60 and High: 100. 3. Respiration Rate (rpm) - low: 12 and High: 22. 4. Body Temperature - low: 36.4 degree Celsius (97.5 degree Fahrenheit) and High: 37.7 degree Celsius (99.5 degree Fahrenheit).

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Percentage of Participants With Clinically Significant Changes From Baseline in Physical Examination Until 24 Hours Post Dose Secondary · From administration of Altropane until 24 hours post dose

Percentage of participants with clinically significant changes from baseline in physical examination (general appearance, lungs and heart).

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Percentage of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Examinations (PR Interval, QTc, QRS and RR Interval) Until 24 Hours Post Dose Secondary · From administration of Altropane until 24 hours post dose

Percentage of participants with clinically significant changes from baseline in electrocardiogram (ECG) examinations: (PR interval, QTc, QRS and RR interval). The normal limits (ms) of ECG variables: 1. PR interval (ms) - low: 120 and high: 200 2. QRS interval (ms) - low: 50 and high: 100 3. QTc interval (ms)- high =\<440 4. RR interval (ms) - low: 600 and high: 1000

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Percentage of Participants With Clinically Significant Changes From Baseline in Serum Biochemistry and Hematology Parameters Until 24 Hours Post Dose Secondary · From administration of Altropane until 24 hours post dose

Percentage of participants with clinically significant changes from baseline in serum biochemistry (Alanine aminotransferase, Albumin, Alkaline phosphatase, Bicarbonate, Creatine phosphokinase (CPK), total Creatinine, Protein (total), Phosphorous Glucose) and hematology parameters (Red blood cell (RBC) count, Platelet count, White blood cell (WBC) count).

Group	Value	95% CI
Part 1: Altropane (123I) Injection	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From administration of Altropane until 24 hours post dose. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Altropane (123I) Injection

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (4 terms — click to expand)

Reaction	System	Part 1: Altropane (123I) I…
Procedural complication	Injury, poisoning and procedural complications	—
Procedural headache	Injury, poisoning and procedural complications	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—
Dizziness	Nervous system disorders	—

Data from ClinicalTrials.gov NCT05636852 adverse events section.

Sponsor's own description

Previous studies showed that a dose of 8 millicuries of Altropane was appropriate for imaging patients with suspected Parkinson's disease. This study determined if a lower dose (5 millicuries) would suffice.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

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NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · recruiting

Other GE Healthcare trials

Trials by the same sponsor.

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NCT06835647 — Maternal Fetal Device Performance Twins · NA · recruiting
NCT06639828 — Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05636852 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GE Healthcare
Last refreshed: 15 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05636852.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing