Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
Recruiting
Phase 3
Interventional Study
Alzheimer Disease
Neurofibrillary Tangle
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 354 (estimated)
- Sponsor
- Sinotau Pharmaceutical Group · Industry
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About This Trial
The goal of this clinical trial is to evaluate the efficacy and safety of XTR006 injection PET visual reading in detecting brain neurofibrillary tangles (NFTs) in elderly subjects with Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), and cognitively normal individuals. The main question it aims to answer is:
• What is the sensitivity and specificity of XTR006 PET visual reading results …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria for All Subjects:
1. Male or female subjects aged ≥50 years.
2. Able to tolerate both PET and MRI examinations.
3. Must use contraceptive measures during the study period and for 6 months after study completion.
4. Written informed consent must be obtained be…
Contacts