CoChat
Sign Up
Cited by 86Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchCholinesterase and Neurodegenerative Diseases

Safety and Efficacy of Idebenone versus Tacrine in Patients with Alzheimer's Disease: Results of a Randomized, Double-Blind, Parallel-Group Multicenter Study

Gutzmann, H., Kühl, K.-P., Hadler, D., Rapp, M. A.·2002·Pharmacopsychiatry
DOI 10.1055/s-2002-19833
Open this paper in CoChat — free account

Abstract

This study evaluated the safety and efficacy of idebenone vs. tacrine in a prospective, randomized, double-blind, parallel-group multicenter study in patients suffering from dementia of the Alzheimer type (DAT) of mild to moderate degree. Diagnosis was based on DSM-III-R (primary degenerative dementia) and NINCDS-ADRDA criteria (probable Alzheimer's disease). A total of 203 patients of both sexes aged between 40 and 90 years were randomized to either idebenone 360 mg/day (n = 104) or tacrine up to 160 mg/day (n = 99) and treated for 60 weeks. The primary outcome measure was the Efficacy Index Score (EIS). The EIS combines dropout as well as the relevant improvements individually across the three levels of assessment (cognitive function, activities of daily living, global function). Secondary outcome measures were the ADAS-Cog score, the NOSGER-IADL score and the clinical global response (CGI-Improvement). After 60 weeks of treatment, 28.8 % of the patients randomized to idebenone, but only 9.1 % of the patients randomized to tacrine were still on the drug. In the LOCF analysis, 50 % of the patients randomized to idebenone but only 39.4 % of the patients randomized to tacrine showed an improvement in the Efficacy Index Score or at least one of the secondary outcome variables. The primary efficacy measurement was the change of the Efficacy Index Score from baseline to the assessment after 60 weeks treatment. The analysis was done on intention-to-treat (ITT) in a before-and-after test design. Patients randomized to idebenone showed a higher benefit from treatment than patients randomized to tacrine. We conclude that the benefit-risk ratio is favorable for idebenone compared to tacrine, and furthermore, that this ratio is likely to be similar when comparing idebenone to other cholinesterase inhibitors.

Integrity signals

Registry

Crossref · 10.1055/s-2002-19833

Cites

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • In two other clinical trials, idebenone was safe and tolerable up to 360 mg/day and slowed progression of cognitive deficits in patients with AD.

    “Subsequently, in two other clinical trials, idebenone was safe and tolerable up to 360 mg/day and slowed progression of cognitive deficits in patients with AD168, 169.”

    From Mitochondrial Approaches for Neuroprotection (2008) · cites this paper as [169]

Cited by

Sorted by citations

Related

Authors
Gutzmann, H., Kühl, K.-P., Hadler, D., & Rapp, M. A.
Affiliations
  • Freie Universität Berlin (DE)
  • Max Planck Society (DE)
ORCID
Rapp, M. A.
Venue
Pharmacopsychiatry
Publisher
Georg Thieme Verlag KG
Published
2002-01
Volume
35
Issue
1
Pages
12-18
ISSN
  • 0176-3679 (ISSN-L)
  • 1439-0795
DOI
10.1055/s-2002-19833
OpenAlex
W1976280412
Cited by
85
References
0
Citations by year
2026: 1 · 2025: 5 · 2024: 1 · 2023: 3 · 2022: 5 · 2021: 3 · 2020: 3 · 2019: 5 · 2018: 1 · 2017: 1 · 2016: 1 · 2015: 5 · 2014: 4 · 2013: 3 · 2012: 1
FWCI
3.00
Type
journal article
Language
en
Open access
closed
Locations
  • Pharmacopsychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • Max Planck Institute for Plasma Physics (submittedVersion)
  • Max Planck Digital Library (submittedVersion)
  • MPG.PuRe (Max Planck Society) (submittedVersion)
Topics
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
Keywords
idebenone, tacrine, Alzheimer's disease, dementia, cholinesterase inhibitors, ADAS-Cog, activities of daily living, treatment efficacy, drug safety, risk-benefit ratio, cognitive function
MeSH terms
Adult, Aged, Aged, 80 and over, Alzheimer Disease, Antioxidants, Double-Blind Method, Female, Humans, Male, Middle Aged, Tacrine, Ubiquinone, Benzoquinones, Treatment Outcome, Nootropic Agents

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review