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O4‐11‐06: A RANDOMIZED, DOUBLE‐BLIND, PLACEBO‐CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CRENEZUMAB IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE
Jeffrey L. Cummings, William Cho, Michael Emmerson Ward, Michel J. Friesenhahn, Flávia Brunstein, Lee A. Honigberg, David Clayton, Deborah L. Mortensen et al.. Alzheimer s & Dementia, 2014-07-01
Topic: Drug trials: efficacy and safety
Crenezumab is a humanized anti-abeta monoclonal antibody in development for the treatment of Alzheimer disease (AD). Crenezumab has been evaluated in a phase 2 clinical study designed to assess its efficacy and safety in patients with mild to moderate AD. The study was conducted in patients 50−80 years of age who were diagnosed with mild to moderate AD with a screening MMSE score of 18 - 26 points.A total of 433 patients were randomized at a 2:1 ratio (active to placebo) to receive either crenezumab or matching placebo for 68 weeks. 184 patients received 300 mg of study drug as a SC injection every 2 weeks and 247 patients received 15mg/kg of study drug as an IV infusion every 4 weeks. Randomization was stratified by ApoE4 status (carrier vs. non-carrier), MMSE score (≤ 21 vs. > 21), and study site. The co-primary efficacy outcome measures were the changes in the ADAS-Cog12 and CDR-SOB scores from baseline to Week 73. The secondary efficacy outcome measure was the change in the ADCS-ADL score from baseline to Week 73. A mixed model for repeated measures analysis was used for statistical analysis of treatment differences at study endpoints. Safety was assessed by monitoring adverse events (AEs), clinical laboratory evaluations, MRI evaluations (ARIA-E and ARIA-H events) and immunogenicity. The ADAS-Cog12, CDR-SOB, and ADCS-ADL endpoints as well as safety data will be presented and discussed This clinical trial was designed to provide an evaluation of the efficacy and safety of crenezumab in AD patients with mild to moderate dementia.
Key findings
- The co-primary efficacy outcome measures were the changes in the ADAS-Cog12 and CDR-SOB scores from baseline to Week 73.
- The secondary efficacy outcome measure was the change in the ADCS-ADL score from baseline to Week 73.
- A mixed model for repeated measures analysis was used for statistical analysis of treatment differences at study endpoints.
- Safety was assessed by monitoring adverse events (AEs), clinical laboratory evaluations, MRI evaluations (ARIA-E and ARIA-H events) and immunogenicity.
- The ADAS-Cog12, CDR-SOB, and ADCS-ADL endpoints as well as safety data will be presented and discussed This clinical trial was designed to provide an evaluation of the efficacy and safety of crenezumab in AD patients with mild to moderate dementia.
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Study details
- Study designclinical trial
- Participants433
- Evidence strengthHigh
How this study scored 55/100
Published in a peer-reviewed journal. Scored zero for study design and effect reported because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 32 of the 58 points we could judge it on, which is 55 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer s & Dementia) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2014 — within 20 year(s) of the newest study here |
| Sample size | 2 / 4 | 433 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | 2 / 2 | Free to read |
| Points | 32 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 32 of the 58 points we could judge it on is 55 out of 100. |
| Total | 55 / 100 | — |
What each of these 20 components measures, and what this score is not →
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APA 7th
Cummings, J. L., Cho, W., Ward, M. E., Friesenhahn, M. J., Brunstein, F., Honigberg, L. A., et al. (2014). O4‐11‐06: A RANDOMIZED, DOUBLE‐BLIND, PLACEBO‐CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CRENEZUMAB IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE. Alzheimer s & Dementia. https://doi.org/10.1016/j.jalz.2014.04.450
Vancouver
Cummings JL, Cho W, Ward ME, Friesenhahn MJ, Brunstein F, Honigberg LA, et al. O4‐11‐06: A RANDOMIZED, DOUBLE‐BLIND, PLACEBO‐CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CRENEZUMAB IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE. Alzheimer s & Dementia. 2014. doi:10.1016/j.jalz.2014.04.450.
BibTeX
@article{cummings2014-a7c335d7,
author = {Cummings, Jeffrey L. and Cho, William and Ward, Michael Emmerson and Friesenhahn, Michel J. and Brunstein, Flávia and Honigberg, Lee A. and Clayton, David and Mortensen, Deborah L. and others},
title = {{O4‐11‐06: A RANDOMIZED, DOUBLE‐BLIND, PLACEBO‐CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CRENEZUMAB IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE}},
journal = {Alzheimer s \& Dementia},
year = {2014},
doi = {10.1016/j.jalz.2014.04.450},
url = {https://doi.org/10.1016/j.jalz.2014.04.450}
}