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Lecanemab for early Alzheimer’s disease: final evidence report
Lecanemab for early Alzheimer’s disease: final evidence report
- Collection:
- Health Policy and Services Research
- Author(s):
- Lin, Grace A., author
Whittington, Melanie D., author
Wright, Abigail, (Of Institute for Clinical and Economic Review), author
Agboola, Foluso, author
Herron-Smith, Serina, author
Pearson, Steven D., author
Rind, David, (Of Institute for Clinical and Economic Review), author - Contributor(s):
- Institute for Clinical and Economic Review, issuing body.
California Technology Assessment Forum (Organization), issuing body. - Publication:
- [Boston, Massachusetts] : Institute for Clinical and Economic Review, April 17, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Alzheimer Disease -- drug therapy
Antibodies, Monoclonal, Humanized
United States - Genre(s):
- Technical Report
- Abstract:
- Lecanemab was evaluated in a Phase III randomized clinical trial, CLARITY AD. The trial randomized 1,795 participants with early Alzheimer disease (i.e., mild cognitive impairment [MCI] or mild dementia due to AD) to a biweekly 10 mg/kg intravenous infusion of lecanemab or placebo. The primary clinical outcome was change in mean score on the Clinical Dementia Rating Scale--Sum of Boxes (CDR-SB). At 18 months, the lecanemab-treated group showed a statistically significant 27% slowing of cognitive decline compared with placebo, representing an average difference of about 0.5 points on the 18-point CDR-SB scale. Analyses of secondary endpoints, including other cognitive measures and patient and caregiver quality of life consistently favored the lecanemab-treated group. Among participants treated with lecanemab, 21.5% experienced amyloid related imaging abnormalities with edema/effusion (ARIA-E), ARIA-hemorrhage or superficial siderosis (ARIA-H), or both compared with 9.5% in the placebo group, and 3.5% of patients in the lecanemab group experienced symptomatic ARIA-E or -H compared with 0.2% in the placebo group. We remain uncertain that amyloid removal is an appropriate surrogate outcome for clinical benefit and instead look to the clinical outcomes found in randomized trials. However, there is disagreement among experts about the clinical meaningfulness of the magnitude of change in CDR SB in the lecanemab trial. We also remain concerned that real world ARIA occurrences and consequences may be more severe if, as expected, monitoring MRIs are not as frequent as in the clinical trial, the patient population treated differs from the trial population, and clinicians are less expert than those who participated in the randomized trial. In aggregate, the net health benefits of lecanemab in patients with early AD may be small or even substantial, but there remains a possibility of net harm from ARIA. We rate treatment with lecanemab in MCI due to AD or mild AD as “Promising but Inconclusive” (P/I).
- Copyright:
- Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
- Extent:
- 1 online resource (1 PDF file (various pagings))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918697384706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918697384706676