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NCT05527288
A Bridging Study on Efficacy and Safety of [18F]Florbetaben PET for Diagnosis of Alzheimer Disease Subjects in Chinese Population
NA trial testing Drug: [18F]florbetaben in Alzheimer Disease in 50 participants. Completed in 12 September 2021.
12 September 2021
Quick facts
| Lead sponsor | Sinotau Pharmaceutical Group |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 50 |
| Start date | 28 January 2021 |
| Primary completion | 12 September 2021 |
| Estimated completion | 12 September 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Drug: [18F]florbetaben — full drug profile →
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Dementia — all drugs for Dementia →
- Brain Diseases — all drugs for Brain Diseases →
- Central Nervous System Diseases — all drugs for Central Nervous System Diseases →
Sponsor
Sinotau Pharmaceutical Group — full company profile →
Who can join
Adults 18 to 85, any sex, with Alzheimer Disease or Dementia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with Alzheimer disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05527288
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Sinotau Pharmaceutical Group trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05527288 (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 Sinotau Pharmaceutical Group
- Last refreshed: 2 September 2022
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/NCT05527288.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing