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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.
Krankenhaus
Hellersdorf, ö.B. Wilhelm-Griesinger-Krankenhaus, Abteilung für
Gerontopsychiatrie, Berlin, Federal Republic of Germany.
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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