Clinical trial · Interventional
PET Imaging of Subjects Using 124I-PU-AD
PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study
NCT03371420CI-TRIAL-00065759terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company has ceased operations
Summary
Brief summary (as posted)
This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Disease | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Solid Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Draws | Other | — | UNRESOLVED |
| PET Scan | Device | — | UNRESOLVED |
| PU-AD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 124I-PU-AD
- description
- A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
- interventionNames
- Drug: PU-AD
- Device: PET Scan
- Other: Blood Draws
Primary outcomes (5)
- measure
- Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)
- timeFrame
- 1 week
- measure
- Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)
- timeFrame
- 1 week
- measure
- Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease: Cancer: 1. Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma. 2. Cancer histology confirmed by pathology. 3. Cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to RECIST 1.1). Alzheimer's: 1. Established diagnosis of mild-moderate Alzheimer's disease based upon neurological and neuropsychological evaluation following the National Institute on Aging - Alzheimer's disease Association criteria that recently revisited the NINCDS-ADRDA criteria. 2. Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist. 2. Subjects who have both cancer and Alzheimer's Disease, subjects are considered eligible if they meet all eligibility requirements for either Alzheimer's Disease or cancer patients, as specified above. Exclusion Criteria: 1. Subject has unacceptable pre-study organ function during screening defined as: 1. Bilirubin \> 1.5 x institutional upper limit of normal (ULN) 2. AST/ALT \>2.5 x ULN 3. Albumin \< 2 g/dl 4. GGT \> 2.5 x ULN (IF Alkaline phosphatase \> 2.5 x ULN) 5. Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min. 2. Subject has history of acute major illness (i.e., unstable cardiovascular condition.) 3. Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.
References
Publications (1)
- DERIVEDBolaender A, Zatorska D, He H, Joshi S, Sharma S, Digwal CS, Patel HJ, Sun W, Imber BS, Ochiana SO, Patel MR, Shrestha L, Shah SK, Wang S, Karimov R, Tao H, Patel PD, Martin AR, Yan P, Panchal P, Almodovar J, Corben A, Rimner A, Ginsberg SD, Lyashchenko S, Burnazi E, Ku A, Kalidindi T, Lee SG, Grkovski M, Beattie BJ, Zanzonico P, Lewis JS, Larson S, Rodina A, Pillarsetty N, Tabar V, Dunphy MP, Taldone T, Shimizu F, Chiosis G. Chemical tools for epichaperome-mediated interactome dysfunctions of the central nervous system. Nat Commun. 2021 Aug 3;12(1):4669. doi: 10.1038/s41467-021-24821-2. PMID 34344873