drugset / Trial / NCT03186989
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease
RandomizedParallel-groupDouble-blindOther
Summary
The purpose of this study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS-MAPTRx in patients with Mild Alzheimer's Disease.
Timeline
- Start
- 2017-10-12
- Primary completion
- 2022-05-12
- Completion
- 2022-05-12
Publications
- Shulman M, Wu S, Ziogas N, Edwards A, Collins J, Lin L, Tien I, Curiale G, Li Y, Mummery C, Lane R, Junge C, Beaver J, Tian Y, Landen J, Bullain S, Gallagher D. Exploratory analyses of clinical outcomes from the BIIB080 phase 1b study in mild Alzheimer's disease. Nat Aging. 2026 Feb;6(2):445-453. doi: 10.1038/s43587-025-01031-9. Epub 2026 Feb 11.
- Lane RM, Darreh-Shori T, Junge C, Li D, Yang Q, Edwards AL, Graham DL, Moore K, Mummery CJ. Onset of Alzheimer disease in apolipoprotein varepsilon4 carriers is earlier in butyrylcholinesterase K variant carriers. BMC Neurol. 2024 Apr 9;24(1):116. doi: 10.1186/s12883-024-03611-5.
- Edwards AL, Collins JA, Junge C, Kordasiewicz H, Mignon L, Wu S, Li Y, Lin L, DuBois J, Hutchison RM, Ziogas N, Shulman M, Martarello L, Graham D, Lane R, Budd Haeberlein S, Beaver J. Exploratory Tau Biomarker Results From a Multiple Ascending-Dose Study of BIIB080 in Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2023 Dec 1;80(12):1344-1352. doi: 10.1001/jamaneurol.2023.3861.
- Mummery CJ, Borjesson-Hanson A, Blackburn DJ, Vijverberg EGB, De Deyn PP, Ducharme S, Jonsson M, Schneider A, Rinne JO, Ludolph AC, Bodenschatz R, Kordasiewicz H, Swayze EE, Fitzsimmons B, Mignon L, Moore KM, Yun C, Baumann T, Li D, Norris DA, Crean R, Graham DL, Huang E, Ratti E, Bennett CF, Junge C, Lane RM. Tau-targeting antisense oligonucleotide MAPTRx in mild Alzheimer's disease: a phase 1b, randomized, placebo-controlled trial. Nat Med. 2023 Jun;29(6):1437-1447. doi: 10.1038/s41591-023-02326-3. Epub 2023 Apr 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIIB080 | Antisense oligonucleotide | 10 mg | Intrathecal |
| Subject | BIIB080 | Antisense oligonucleotide | 30 mg | Intrathecal |
| Subject | BIIB080 | Antisense oligonucleotide | 60 mg | Intrathecal |
| Subject | BIIB080 | Antisense oligonucleotide | 115 mg | Intrathecal |