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74/100

✓ Peer-reviewed alzhub usefulness score 74 out of 100. Treatments

Topic: Amyloid, tau and blood-test diagnosis

Introduction The aim of the study was to assess the clinical efficacy, safety, and disease-modification effects of tramiprosate (homotaurine, ALZHEMED(TM)) in mild-to-moderate Alzheimer's disease (AD). Material and methods Double-blind, placebo-controlled, randomized trial in 67 clinical centres across North America. Patients aged ≥ 50 years, with mild-to-moderate AD (Mini-Mental State Examination score between 16 and 26) and on stable doses of cholinesterase inhibitors, alone or with memantine. Intervention 78-week treatment with placebo, tramiprosate 100 mg or tramiprosate 150 mg BID. Measurements Alzheimer Disease Assessment Scale - cognitive subscale (ADAS-cog) and Clinical Dementia Rating - Sum of Boxes (CDR-SB) assessments were performed at baseline and every 13 weeks. Baseline and 78-week magnetic resonance imaging (MRI) hippocampus volume (HV) measurements were conducted in a subgroup of patients. Results A total of 1,052 patients were enrolled and 790 (75.1%) completed the 78-week trial. Patient discontinuation and reasons for withdrawal were similar across groups. Planned analyses did not reveal statistically significant between-group differences. Lack of adequate statistical validity of the planned analysis models led to the development of revised predictive models. These adjusted models showed a trend toward a treatment effect for ADAS-cog (P = 0.098) and indicated significantly less HV loss for tramiprosate 100 mg (P = 0.035) and 150 mg (P = 0.009) compared to placebo. The incidence of adverse events was similar across treatment groups. Conclusions The primary planned analyses did not show a significant treatment effect, but were confounded by unexplained variance. Post-hoc analyses showed a significant treatment-related reduction in HV loss. However, there was only a trend towards slowing of decline on the ADAS-cog and no slowing of decline on the CDR-SB. These results must be interpreted in consideration of the limitations of clinical and disease-modification outcome measures and their relationship, the heterogeneity of the disease and the impact of confounding demographic and clinical variables.

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APA 7th

Aisen, P. S., Gauthier, S., Ferris, S. H., Saumier, D., Haine, D., Garceau, D., et al. (2011). Tramiprosate in mild-to-moderate Alzheimer's disease - a randomized, double-blind, placebo-controlled, multi-centre study (the Alphase Study). Archives of medical science : AMS. https://doi.org/10.5114/aoms.2011.20612

Vancouver

Aisen PS, Gauthier S, Ferris SH, Saumier D, Haine D, Garceau D, et al. Tramiprosate in mild-to-moderate Alzheimer's disease - a randomized, double-blind, placebo-controlled, multi-centre study (the Alphase Study). Archives of medical science : AMS. 2011. doi:10.5114/aoms.2011.20612. PMID: 22291741.

BibTeX

@article{aisen2011-22291741,
  author  = {Aisen, P. S. and Gauthier, S. and Ferris, S. H. and Saumier, D. and Haine, D. and Garceau, D. and Duong, A. and Suhy, J. and others},
  title   = {{Tramiprosate in mild-to-moderate Alzheimer's disease - a randomized, double-blind, placebo-controlled, multi-centre study (the Alphase Study)}},
  journal = {Archives of medical science : AMS},
  year    = {2011},
  doi     = {10.5114/aoms.2011.20612},
  pmid    = {22291741},
  url     = {https://doi.org/10.5114/aoms.2011.20612}
}

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Key findings

Results A total of 1,052 patients were enrolled and 790 (75.1%) completed the 78-week trial.
Planned analyses did not reveal statistically significant between-group differences.
These adjusted models showed a trend toward a treatment effect for ADAS-cog (P = 0.098) and indicated significantly less HV loss for tramiprosate 100 mg (P = 0.035) and 150 mg (P = 0.009) compared to placebo.
Conclusions The primary planned analyses did not show a significant treatment effect, but were confounded by unexplained variance.
Post-hoc analyses showed a significant treatment-related reduction in HV loss.

Why it matters

In this 78-week trial, the planned analyses found no statistically significant differences between tramiprosate and placebo. Only after using adjusted models was a trend toward a treatment effect on cognition seen, and less hippocampus volume loss was found for both tramiprosate doses compared to placebo.

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Study details

Study designrandomized controlled trial
Participants1,052
Effect size75.1%
Evidence strengthHigh

How this study scored 74/100

Published in a peer-reviewed journal, and it is a randomised controlled trial.

Component	Points	Why
Journal tier	7 / 10	Tier 3 — peer-reviewed journal (Archives of medical science : AMS)
Journal's citation record	1 / 4	Archives of Medical Science: journal h-index 77 (OpenAlex, 2026-10-29)
Study design	11 / 12	A randomised 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	3 / 4	1,052 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	2 / 2	Randomised and blinded or placebo-controlled (as stated in the record)
Times cited	5 / 7	Cited 295 times (OpenAlex, 2026-10-10)
Citations per year	3 / 5	17.4 citations a year over 17 year(s) since 2011
Impact for its field and year	4 / 6	Cited 12.2× the average for papers of its field and year (OpenAlex FWCI)
Cited by studies here	3 / 6	Cited by 12 other studies in this library
Still being cited	3 / 4	Cited 58 times in 2024–2026 (2026 still in progress; OpenAlex)
Senior author's track record	3 / 4	Last-listed author John S. Sampalis: h-index 53 (OpenAlex, whole career)
Institution's track record	2 / 3	University of California San Diego: institution h-index 1,852 (OpenAlex)
Multi-centre collaboration	2 / 3	OpenAlex lists 7 institution(s) in 2 countries
Indexed in PubMed	2 / 2	Indexed in PubMed (PMID 22291741)
Free to read	2 / 2	Free to read
Total	74 / 100	—

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