Drug updated on 9/4/2024
| Dosage Form | Injection (intravenous; 300 MBq/mL to 1,900 MBq/mL [8.1 mCi/mL to 51 mCi/mL] of flortaucipir F 18 injection in a multiple-dose vial) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).
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Summary
- Tauvid (flortaucipir F18) is indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).
- This summary is based on the review of one randomized controlled trial(s). [1]
- Clinical Deterioration in Advanced AD Pattern: 70% of participants with advanced AD pattern showed a clinically meaningful increase in CDR-SB (≥1 point) over 18 months. Risk Ratio (RR) for clinical deterioration was 1.40 (95% CI, 1.11-1.76; P = .005) compared to those with nonadvanced AD pattern.
- Clinical Deterioration in Nonadvanced AD Pattern: 46% of participants with nonadvanced AD pattern exhibited a clinically meaningful increase in CDR-SB (≥1 point) over 18 months. The adjusted mean CDR-SB change was 0.98, significantly lower than the 2.28 change observed in the advanced AD pattern group (P < .001).
- Consistency Across Clinical End Points: The findings were consistent across different clinical end point assessments and individual study data, indicating robust evidence for the outcomes measured.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tauvid (flortaucipir F18) Prescribing Information. | 2024 | Avid Radiopharmaceuticals, Philadelphia, PA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Aggregated tau measured by visual interpretation of flortaucipir positron emission tomography and the associated risk of clinical progression of mild cognitive impairment and Alzheimer disease: results from 2 phase III clinical trials. | Data not availableSubjects F: null% M: null% | 2021 | JAMA Neurology |
Sex Distribution:
Year:
2021
Source:JAMA Neurology