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Intravenous immunoglobulin for Alzheimer's disease
Norman R. Relkin. Clinical & Experimental Immunology, 2014-12-01
Topic: Drug trials: efficacy and safety
Initial studies suggested that IVIg contained antibodies against monomeric forms of Aβ 5. These small, open-label studies provided some encouraging results, including improvements in cognitive test scores in addition to alterations in the levels of circulating Aβ indicating target engagement. In the US Phase I study, washout of IVIg during 3 months led to a return to the pretreatment baseline cognitive status, suggesting that IVIg treatment needed to be sustained to provide benefit. After 6 months, IVIg-treated subjects (n = 16) had statistically superior Clinical Global Impression of Change (CGIC) ratings and numerically superior outcomes on the Alzheimer's disease assessment scale – cognition (ADAS-Cog) compared to placebo-treated patients (n = 8). No significant difference was observed on either of these measures in the intent-to-treat analysis or protocol analyses. Biomarker studies revealed dose-dependent increases in immunoglobulins in plasma and cerebrospinal fluid (CSF) and decreases in plasma beta amyloid-42 levels 16. IVIg treatment resulted in measurable alterations in plasma amyloid levels, suggesting that the naturally occurring anti-amyloid antibodies may play a role in clearing amyloid from the body. The results of the IVIg studies to date must be considered in context. However, in a preplanned subgroup analysis pooling results of two of the Sola Phase III trials, positive signals were obtained on cognitive measures in the mildly affected AD patients. In the case of AN-1792 and Bapi, evidence of significant plaque reduction was obtained either by postmortem studies and PET imaging, respectively. In neither case was this associated with significant clinical benefits. The failure of AN-1792 and Bapi to produce positive clinical outcomes despite reducing fibrillar brain amyloid suggests that plaque removal alone is inadequate to arrest the progression of symptomatic AD.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Relkin, N. R. (2014). Intravenous immunoglobulin for Alzheimer's disease. Clinical & Experimental Immunology. https://doi.org/10.1111/cei.12500
Vancouver
Relkin NR. Intravenous immunoglobulin for Alzheimer's disease. Clinical & Experimental Immunology. 2014. doi:10.1111/cei.12500. PMID: 25546751.
BibTeX
@article{relkin2014-25546751,
author = {Relkin, Norman R.},
title = {{Intravenous immunoglobulin for Alzheimer's disease}},
journal = {Clinical \& Experimental Immunology},
year = {2014},
doi = {10.1111/cei.12500},
pmid = {25546751},
url = {https://doi.org/10.1111/cei.12500}
}
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Key findings
- Initial studies suggested that IVIg contained antibodies against monomeric forms of Aβ 5.
- These small, open-label studies provided some encouraging results, including improvements in cognitive test scores in addition to alterations in the levels of circulating Aβ indicating target engagement.
- In the US Phase I study, washout of IVIg during 3 months led to a return to the pretreatment baseline cognitive status, suggesting that IVIg treatment needed to be sustained to provide benefit.
- After 6 months, IVIg-treated subjects (n = 16) had statistically superior Clinical Global Impression of Change (CGIC) ratings and numerically superior outcomes on the Alzheimer's disease assessment scale – cognition (ADAS-Cog) compared to placebo-treated patients (n = 8).
- No significant difference was observed on either of these measures in the intent-to-treat analysis or protocol analyses.
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Study details
- Study designopen-label trial
- Participants16
- Evidence strengthLow
How this study scored 47/100
Published in a peer-reviewed journal. Scored zero for study design, effect reported and randomised / blinded 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 27 of the 58 points we could judge it on, which is 47 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Clinical & Experimental Immunology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | Design recorded as “open-label trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” 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 | 1 / 4 | 16 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 | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| 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 25546751) |
| Free to read | 2 / 2 | Free to read |
| Points | 27 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 27 of the 58 points we could judge it on is 47 out of 100. |
| Total | 47 / 100 | — |
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