Donepezil is the first and only acetylcholin-
esterase inhibitor (AChEI) that is licensed
for the treatment of severe Alzheimer disease
(AD)
1
, but the maintenance of continuous
treatment with AChEIs in advanced stages of
the disease is being questioned. In the recently
published DOMINO-AD study
2
, Howard et al.
investigated how discontinuation of donepezil
treatment for patients with moderate to severe
AD affects their nursing home placement
(NHP). The results provide some evidence
that withdrawal of the drug increases the risk
of NHP, but the analysis raises questions about
the management of these patients.
AD is the most common cause of demen-
tia in the ageing population. The progressive
course of the disease results in cognitive and
functional decline that has several effects:
it influences quality of life for patients and
caregivers, successively increases the need for
informal care and, in advanced stages of the
disease, necessitates costly institutionalization
that drains social care resources.
Data from the large Swedish Dementia
Registry (SveDem) show that >80% of patients
with AD are treated with anti-dementia drugs
4
.
Symptomatic treatment with AChEIs and/or
the N-methyl-d-aspartate receptor antagonist
memantine has been shown to improve or
stabilize scores on cognitive and functional
measures, and on measures of global clin-
ical change, regardless of disease severity
3
.
Donepezil is a potent, selective, noncompet-
itive and rapidly reversible AChEI
1
. The effi-
cacy of donepezil alone or in combination
shown that treatment with donepezil is either
cost-neutral or cost-saving
6
, but in an inde-
pendent societal study in the UK, the AD2000
Collaborative Group reported that improve-
ments in functional ability after treatment with
donepezil would not delay NHP sufficiently to
justify the costs of the drug
7
.
The aim of the DOMINO-AD study was
to determine how the NHP of patients who
were receiving donepezil for moderate to
severe AD was affected by continuation or
discontinuation of donepezil treatment and
either starting or not starting memantine
treatment
2
. The study was a 1-year rand-
omized double-blind placebo-controlled
multicentre trial with an additional 3-year
double-blind follow-up. The trial involved
15 secondary care memory centres in England
and Scotland. In contrast to previous clinical
trials of AChEIs, the inclusion and exclusion
criteria for the DOMINO-AD study were
relatively unselective to ensure that results
were generalizable.
Discontinuation of donepezil treatment
was associated with an increased risk of NHP
within 12 months; the risk was highest dur-
ing the first 6 months. Beyond 12 months,
patients who discontinued donepezil treat-
ment were at no higher risk of NHP than
were patients who continued treatment.
Memantine, either alone or in combination
with donepezil, had no effect on the risk of
NHP. The delay of NHP among patients
who continued donepezil treatment seems
to have been driven by better cognition and
ability to perform activities of daily living
than in patients who discontinued donepe-
zil treatment: the mean difference in scores
between these groups were 1.9 points on the
Standardized Mini-Mental State Examination,
and 3 points on the Bristol Activities of Daily
Living Scale. The results indicate that pro-
longed treatment of six patients with severe
dementia is needed to prevent one NHP. The
study has been criticized for being under-
powered for analysis of the secondary out-
come of NHP
8
. Nevertheless, by reporting on
the effects of AChEI withdrawal, the authors
of DOMINO-AD have opened up a debate
around whether the effects of AChEI therapy
on NHP provide sufficient benefit to justify its
continuation even in advanced stages of the
disease, and whether combination treatment
has any additional benefit.
with memantine has been demonstrated by
several short-term (≤24 months) randomized
double-blind placebo-controlled clinical tri-
als, and by long-term extension trials and
observational studies
1
.
Despite the demonstrated efficacy of
AChEIs, whether or not treatment with them
should be continued in the advanced stages of
AD is still a matter of debate. In addition, there
is only weak evidence for a clinical benefit of
combination therapy with AChEI and meman-
tine, the most consistently used approach
for the management of dementia-related
behavioural symptoms in advanced AD
5
.
Methodological problems hinder the design-
ing of long-term pragmatic trials that could
address these issues, and prevent clinically
meaningful outcomes and efficacy measures in
severe AD from being defined. Furthermore,
many regulatory authorities require not only
evidence of a drug effect, but also of the cost
effectiveness of a drug before they permit the
development of clinical practice guidelines and
reimbursement recommendations.
NHP is an important milestone in the
course of dementia, marks a shift from moder-
ate to severe disease and dramatically increases
the cost of care. Several modelling studies have
ALZHEIMER DISEASE
Donepezil and nursing home
placement — benefits and costs
Vesna Jelic and Bengt Winblad
The recent DOMINO‑AD trial suggests that continued treatment with
donepezil delays nursing home placement for patients with severe
Alzheimer disease, but more work is needed to support strong conclusions
about whether the benefits outweigh the costs.
Refers to Howard, R. et al. Nursing home placement in the Donepezil and Memantine in Moderate to Severe
Alzheimer’s Disease (DOMINO‑AD) trial: secondary and post‑hoc analysis. Lancet Neurol. http://dx.doi.org/10.1016/
S1474‑4422(15)00258‑6
Nursing home placement …
is an important milestone in the
course of dementia
NATURE REVIEWS | NEUROLOGY VOLUME 12 | JANUARY 2016
NEWS & VIEWS
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