A Controlled Study of 2 Doses of Idebenone in the Treatment of Alzheimer’s Disease
Abstract
Two doses of idebenone were studied in a prospective, randomized, double-blind, placebo-controlled multicentre 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 300 patients were randomized to either placebo, idebenone 30 mg t.i.d. or 90 mg t.i.d. (n = 100, each) and treated for 6 months. 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 non-cognitive scores (ADAS-Noncog), the clinical global response (CGI-Improve-ment), the MMSE, the Digit Symbol Substitution test (DSS) and several scales for the assessment of daily activities (the self- and observer-rating scales NAA and NAB of the Nuremberg Age Inventory NAI and Greene’s Assessment). Safety parameters were adverse events, vital signs, ECG and clinical laboratory parameters. Clinical and psychometric evaluations were performed at baseline, and after 1, 3 and 6 months of treatment. After month 6 idebenone 90 mg t.i.d. showed statistically significant improvement in the primary efficacy variable ADAS-Total and in ADAS-Cog. An analysis of therapy responders performed for 3 outcome measures (CGI-global improvement, ADAS-Cog, ADAS-Noncog), selected to represent different domains of assessment, revealed significant superiority of idebenone 90 mg t.i.d. with respect to placebo in each of the 3 variables and in the concordance of responses across the 3 measures. Exploratory results for a subgroup of patients (ADAS-Total > 20) showed dose-related superiority of idebenone additionally on ADAS-Noncog and the CGI-Improvement scale. Safety results were inconspicuous for all assessments. The study results demonstrate the efficacy and safety of idebenone in the treatment of DAT patients.
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In a randomized, double-blind, placebo-controlled multicentre study of 300 patients with Alzheimer type dementia treated for 2 years with 30 or 90 mg/day idebenone or placebo, there was a statistically significant improvement in ADAS score after 6 months, in a dose dependent manner.
“The outcome of study was a statistically significant improvement in the Alzheimer's Disease Assessment Scale (ADAS) score after 6 months, in a dose dependent manner.”
From Mitochondrial Approaches for Neuroprotection (2008) · cites this paper as [167]
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- Authors
- Weyer, G., Babej-Dölle, R. M., Hadler, D., Hofmann, S., & Herrmann, W. M.
- Affiliations
- Goethe University Frankfurt (DE)
- Freie Universität Berlin (DE)
- ORCID
- Weyer, G.
- Venue
- Neuropsychobiology
- Publisher
- S. Karger AG
- Published
- 2008-02-26
- Volume
- 36
- Issue
- 2
- Pages
- 73-82
- ISSN
- 0302-282X (ISSN-L)
- 1423-0224
- OpenAlex
- W2077893977
- Cited by
- 120
- References
- 0
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 1 · 2023: 5 · 2022: 3 · 2021: 6 · 2020: 3 · 2019: 7 · 2018: 3 · 2017: 3 · 2016: 1 · 2015: 4 · 2014: 7 · 2013: 7 · 2012: 4
- FWCI
- 5.64
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Neuropsychobiology (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, dementia, dose comparison, cognitive function, treatment efficacy, drug safety, ADAS-Cog
- MeSH terms
- Aged, Aged, 80 and over, Alzheimer Disease, Cognition, Double-Blind Method, Female, Humans, Male, Middle Aged, Ubiquinone, Benzoquinones, Treatment Outcome
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