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Cited by 162Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchNeurological Disorders and Treatments

Sustained efficacy and safety of idebenone in the treatment of Alzheimer’s disease: update on a 2-year double-blind multicentre study

Gutzmann, H., Hadler, D.·1998·Journal of Neural Transmission. Supplementa
DOI 10.1007/978-3-7091-7508-8_30
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Abstract

The 2-year efficacy and safety of idebenone were studied in a prospective, randomized, double-blind multicentre study in 3 parallel groups of patients with dementia of the Alzheimer type (DAT) of mild to moderate degree. A total of 450 patients were randomized to either placebo for 12 months, followed by idebenone 90 mg tid for another 12 months (n = 153) or idebenone 90 mg tid for 24 months (n = 148) or 120 mg tid for 24 months (n = 149). The primary outcome measure was the total score of the Alzheimer's Disease Assessment Scale (ADAS-Total) at month 6. Secondary outcome measures were the ADAS cognitive (ADAS-Cog) and noncognitive score (ADAS-Noncog), the clinical global response (CGI-Improvement), the SKT neuropsychological test battery, and the Nurses' Observation Scale for Geriatric Patients (NOSGER-Total and IADL subscale). Safety parameters were adverse events, vital signs, ECG and clinical laboratory parameters. During the placebo controlled period (the first year of treatment), idebenone showed statistically significant dose-dependent improvement in the primary efficacy variable ADAS-Total and in all the secondary efficacy variables. There was no evidence for a loss of efficacy during the second year of treatment, as a further improvement of most efficacy variables was found in the second year in comparison to the results at the 12 months visit. Also, a clear dose effect relationship (placebo/90 mg < idebenone 90 mg < idebenone 120 mg) was maintained throughout the second year of treatment. This suggests that idebenone exerts its beneficial therapeutic effects on the course of the disease by slowing down its progression. Safety and tolerability of idebenone were good and similar to placebo during the first year of treatment and did not change during the second year.

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  • 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 [168]

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Authors
Gutzmann, H., & Hadler, D.
Venue
Journal of Neural Transmission. Supplementa
Publisher
Springer Vienna
Published
1998
Volume
54
Pages
301-310
ISSN
0303-6995 (ISSN-L)
DOI
10.1007/978-3-7091-7508-8_30
OpenAlex
W66952839
Cited by
162
References
20
Citations by year
2025: 4 · 2024: 2 · 2023: 9 · 2022: 4 · 2021: 8 · 2020: 7 · 2019: 4 · 2018: 6 · 2017: 3 · 2016: 8 · 2015: 6 · 2014: 7 · 2013: 7 · 2012: 5
FWCI
12.73
Type
book chapter
Language
en
Open access
closed
Locations
  • Journal of neural transmission. Supplementum (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Life Sciences › Neuroscience › Neurology › Neurological Disorders and Treatments
Keywords
idebenone, Alzheimer's disease, Alzheimer-type dementia, long-term efficacy, drug safety and tolerability, dose-dependent effects, disease progression, cognitive function, activities of daily living, adverse events
MeSH terms
Adult, Aged, Aged, 80 and over, Alzheimer Disease, Antioxidants, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Psychiatric Status Rating Scales, Time Factors, Ubiquinone, Benzoquinones

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