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Active Aβ immunotherapy CAD106 in Alzheimer's disease: A phase 2b study
Vandenberghe R, Riviere ME, Caputo A, Sovago J, Maguire RP, Farlow M, Marotta G, Sanchez-Valle R et al.. Alzheimer's & dementia (New York, N. Y.), 2016-12-23
Topic: Amyloid, tau and blood-test diagnosis
Introduction This randomized, double-blind, placebo-controlled, 90-week study assessed safety, tolerability, and immunogenicity of CAD106 with/without adjuvant in patients with mild Alzheimer's disease. Methods One hundred twenty-one patients received up to seven intramuscular injections of CAD106 (150 μg or 450 μg) or placebo ± adjuvant over 60 weeks. An amyloid positron emission tomography (PET) substudy was also conducted. Results CAD106 induced strong serological responses (amyloid-beta [Aβ]-Immunoglobuline G[IgG]) in 55.1% (150 μg) and 81.1% (450 μg) of patients (strong serological responders [SSRs]). Serious adverse events (SAEs) were reported in 24.5% (95% confidence interval [CI] 16.7-33.8) of the patients in the active treatment group and in 6.7% (95% CI 0.2-31.9) in the placebo group. Three of the SAEs were classified as possibly related to study drug by the investigators. No evidence of central nervous system inflammation was found. Amyloid-related imaging abnormalities (ARIAs) occurred in six cases, all of them were strong serological responders. None of the ARIAs were symptomatic. Serum Aβ-IgG titer area under the curves correlated negatively with amyloid PET standardized uptake value ratio percentage change from baseline to week 78 within the CAD106-treated patients (r = -0.84, P = .0004). Decrease in cortical gray-matter volume from baseline to week 78 was larger in SSRs than in controls ( P = .0077). Discussion Repeated CAD106 administration was generally well tolerated. CAD106 450 μg with alum adjuvant demonstrated the best balance between antibody response and tolerability.
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APA 7th
Vandenberghe, R., Riviere, M. E., Caputo, A., Sovago, J., Maguire, R. P., Farlow, M., et al. (2017). Active Aβ immunotherapy CAD106 in Alzheimer's disease: A phase 2b study. Alzheimer's & dementia (New York, N. Y.). https://doi.org/10.1016/j.trci.2016.12.003
Vancouver
Vandenberghe R, Riviere ME, Caputo A, Sovago J, Maguire RP, Farlow M, et al. Active Aβ immunotherapy CAD106 in Alzheimer's disease: A phase 2b study. Alzheimer's & dementia (New York, N. Y.). 2017. doi:10.1016/j.trci.2016.12.003. PMID: 29067316.
BibTeX
@article{vandenberghe2017-29067316,
author = {Vandenberghe, R. and Riviere, M. E. and Caputo, A. and Sovago, J. and Maguire, R. P. and Farlow, M. and Marotta, G. and Sanchez-Valle, R. and others},
title = {{Active Aβ immunotherapy CAD106 in Alzheimer's disease: A phase 2b study}},
journal = {Alzheimer's \& dementia (New York, N. Y.)},
year = {2017},
doi = {10.1016/j.trci.2016.12.003},
pmid = {29067316},
url = {https://doi.org/10.1016/j.trci.2016.12.003}
}
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Key findings
- Results CAD106 induced strong serological responses (amyloid-beta [Aβ]-Immunoglobuline G[IgG]) in 55.1% (150 μg) and 81.1% (450 μg) of patients (strong serological responders [SSRs]).
- CAD106 450 μg with alum adjuvant demonstrated the best balance between antibody response and tolerability.
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Study details
- Effect size55.1%; 81.1%; 24.5%
- Evidence strengthHigh
How this study scored 57/100
Published in a leading specialty journal. Scored zero for study design, sample size and studied in people 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 33 of the 58 points we could judge it on, which is 57 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia (New York, N. Y.)) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (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 | 2 / 5 | 2017 — within 10 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| 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 | 2 / 2 | Indexed in PubMed (PMID 29067316) |
| Free to read | 2 / 2 | Free to read |
| Points | 33 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 33 of the 58 points we could judge it on is 57 out of 100. |
| Total | 57 / 100 | — |
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