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EHT0202 in Alzheimer's disease: a 3-month, randomized, placebo-controlled, double-blind study
Vellas B, Sol O, Snyder PJ, Ousset PJ, Haddad R, Maurin M, Lemarié JC, Désiré L et al.. Current Alzheimer research, 2011-03-01
Topic: Amyloid, tau and blood-test diagnosis
Plain-language summary
Background EHT0202 (etazolate hydrochloride) is a new compound exhibiting both potential disease-modifying and symptomatic treatment properties in Alzheimer's Disease increasing alpha-secretase activity and sAPP alpha secretion, as well as acting as a GABA-A receptor modulator and as a PDE-4 inhibitor. Methods This pilot, randomized, double-blind, placebo-controlled, parallel group, multicentre, Phase IIA study was conducted in 159 randomized patients suffering from mild to moderate Alzheimer's Disease. EHT0202 (40 or 80 mg bid) or placebo was administered as adjunctive therapy to one acetylcholinesterase inhibitor over a 3-month period. This study was designed to assess the clinical safety and tolerability of EHT0202 as a primary objective, with secondary endpoints (cognitive function, daily living activities, behaviour, caregiver burden and global functioning) included to explore clinical efficacy of EHT0202 versus placebo. Results EHT0202 was shown to be safe and generally well tolerated. Dose-dependent numbers of early withdrawal and central nervous system related adverse events were observed. As expected, since the study was not powered and not designed to show drug efficacy, and except for ratings on the ADCS-ADL scale, no significant differences were seen between treatment groups. Conclusions These first encouraging safety results do support further development of EHT0202 in order to assess its clinical efficacy and to confirm its tolerability in a larger cohort of Alzheimer patients and for a longer period.
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APA 7th
Vellas, B., Sol, O., Snyder, P. J., Ousset, P. J., Haddad, R., Maurin, M., et al. (2011). EHT0202 in Alzheimer's disease: a 3-month, randomized, placebo-controlled, double-blind study. Current Alzheimer research. https://doi.org/10.2174/156720511795256053
Vancouver
Vellas B, Sol O, Snyder PJ, Ousset PJ, Haddad R, Maurin M, et al. EHT0202 in Alzheimer's disease: a 3-month, randomized, placebo-controlled, double-blind study. Current Alzheimer research. 2011. doi:10.2174/156720511795256053. PMID: 21222604.
BibTeX
@article{vellas2011-21222604,
author = {Vellas, B. and Sol, O. and Snyder, P. J. and Ousset, P. J. and Haddad, R. and Maurin, M. and Lemarié, J. C. and Désiré, L. and others},
title = {{EHT0202 in Alzheimer's disease: a 3-month, randomized, placebo-controlled, double-blind study}},
journal = {Current Alzheimer research},
year = {2011},
doi = {10.2174/156720511795256053},
pmid = {21222604},
url = {https://doi.org/10.2174/156720511795256053}
}
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Key findings
- This study was designed to assess the clinical safety and tolerability of EHT0202 as a primary objective, with secondary endpoints (cognitive function, daily living activities, behaviour, caregiver burden and global functioning) included to explore clinical efficacy of EHT0202 versus placebo.
- Results EHT0202 was shown to be safe and generally well tolerated.
- As expected, since the study was not powered and not designed to show drug efficacy, and except for ratings on the ADCS-ADL scale, no significant differences were seen between treatment groups.
- Conclusions These first encouraging safety results do support further development of EHT0202 in order to assess its clinical efficacy and to confirm its tolerability in a larger cohort of Alzheimer patients and for a longer period.
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Study details
- Evidence strengthHigh
How this study scored 71/100
Published in a peer-reviewed journal, and it is a randomized controlled trial. Scored zero for sample size 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 multicenter collaboration, so those were left out: it earned 41 of the 58 points we could judge it on, which is 71 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Current Alzheimer research) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomized controlled trial (from PubMed type “Randomized Controlled Trial”) |
| 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 | 2011 — within 20 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 | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (pubmed indexes it as a clinical or observational study) |
| Randomized / blinded | 2 / 2 | Randomized and blinded or placebo-controlled (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 |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 21222604) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 41 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 41 of the 58 points we could judge it on is 71 out of 100. |
| Total | 71 / 100 | — |
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