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Change in Digital Cognitive Test Performance between Solanezumab and Placebo Groups in Preclinical Alzheimer's Disease: Secondary Analyses from the A4 Study
Papp KV, Maruff P, Rentz DM, Donohue MC, Liu A, Aisen PS, Sperling RA.. The journal of prevention of Alzheimer's disease, 2024-01-01
Topic: Amyloid, tau and blood-test diagnosis
Background Primary results from the Anti-Amyloid in Asymptomatic Alzheimer's disease Study (A4) suggested no benefit of solanezumab on its primary cognitive outcome, a composite of paper and pencil tests (the Preclinical Alzheimer's Cognitive Composite; PACC). Objective To determine whether change in cognitive performance, assessed using the Computerized Cognitive Composite (C3) summary score and C3 individual tests, differed between treatment groups over 240 weeks, differed based on baseline Aβ burden, and tracked with PACC decline. Design Longitudinal analysis of cognitive change over 240 weeks on the C3 Summary Score and C3 individual tests between participants randomly assigned to solanezumab at a dose of up to 1600 mg intravenously every 4 weeks versus placebo. Setting The A4 study took place at 67 sites in Australia, Canada, Japan and the United States. Participants Cognitively unimpaired older adults (n=1117, Mean Age=71.9, 60.7% female) with elevated brain amyloid levels on 18F-florbetapir positron-emission tomography (PET) at baseline (n=549 in the solanezumab group; n=568 in the placebo group). Measurements Participants completed the C3 battery and PACC every 6 months. The C3 Summary Score combines the Cogstate Brief Battery (CBB)-One Card Learning, the Behavioral Pattern Separation (BPS) Test- Object- Lure Discrimination Index, and the Face Name Associative Memory Exam (FNAME)- Face-Name Matching. Results Change on the C3 Summary Score was moderately correlated with change on the PACC (Spearman's corr=0.53, 95% CI: 0.49 to 0.57; p<0.001). At 240 weeks, mean change in the C3 Summary Score did not differ between groups; +0.24 in the solanezumab group and +0.27 in the placebo group (mean difference= -0.02; 95% CI: -0.13 to 0.08; p = 0.650). Lack of a treatment effect was similarly observed across most individual C3 tests. Performance on the C3 tests were influenced by level of amyloid burden, where higher levels were associated with worse performance. Conclusion This study provides corroborating evidence that solanezumab does not slow cognitive decline in preclinical AD as exhibited with a computerized cognitive assessment with some evidence that solanezumab may exacerbate cognition on select digital outcomes. This study also provides important information that amyloid related cognitive change manifests differently on individual C3 tests.
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APA 7th
Papp, K. V., Maruff, P., Rentz, D. M., Donohue, M. C., Liu, A., Aisen, P. S., et al. (2024). Change in Digital Cognitive Test Performance between Solanezumab and Placebo Groups in Preclinical Alzheimer's Disease: Secondary Analyses from the A4 Study. The journal of prevention of Alzheimer's disease. https://doi.org/10.14283/jpad.2024.137
Vancouver
Papp KV, Maruff P, Rentz DM, Donohue MC, Liu A, Aisen PS, et al. Change in Digital Cognitive Test Performance between Solanezumab and Placebo Groups in Preclinical Alzheimer's Disease: Secondary Analyses from the A4 Study. The journal of prevention of Alzheimer's disease. 2024. doi:10.14283/jpad.2024.137. PMID: 39044493.
BibTeX
@article{papp2024-39044493,
author = {Papp, K. V. and Maruff, P. and Rentz, D. M. and Donohue, M. C. and Liu, A. and Aisen, P. S. and Sperling, R. A.},
title = {{Change in Digital Cognitive Test Performance between Solanezumab and Placebo Groups in Preclinical Alzheimer's Disease: Secondary Analyses from the A4 Study}},
journal = {The journal of prevention of Alzheimer's disease},
year = {2024},
doi = {10.14283/jpad.2024.137},
pmid = {39044493},
url = {https://doi.org/10.14283/jpad.2024.137}
}
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Key findings
- Background Primary results from the Anti-Amyloid in Asymptomatic Alzheimer's disease Study (A4) suggested no benefit of solanezumab on its primary cognitive outcome, a composite of paper and pencil tests (the Preclinical Alzheimer's Cognitive Composite; PACC).
- Design Longitudinal analysis of cognitive change over 240 weeks on the C3 Summary Score and C3 individual tests between participants randomly assigned to solanezumab at a dose of up to 1600 mg intravenously every 4 weeks versus placebo.
- Results Change on the C3 Summary Score was moderately correlated with change on the PACC (Spearman's corr=0.53, 95% CI: 0.49 to 0.57; p<0.001).
- Performance on the C3 tests were influenced by level of amyloid burden, where higher levels were associated with worse performance.
Study details
- Study designlongitudinal study
- Participants1,117
- Effect size60.7%; rr=0.53
- Evidence strengthModerate
How this study scored 82/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. 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 and institution's track record, so those were left out: it earned 50 of the 61 points we could judge it on, which is 82 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The journal of prevention of Alzheimer's disease) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 3 / 5 | Rated “moderate” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2024 — within 3 year(s) of the newest study here |
| Sample size | 3 / 4 | 1,117 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| 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 | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 39044493) |
| Free to read | 2 / 2 | Free to read |
| Points | 50 / 61 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 50 of the 61 points we could judge it on is 82 out of 100. |
| Total | 82 / 100 | — |
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