| Press Release
October 11, 2006
Antipsychotic Medications Used to Treat
Alzheimer’s Patients Found Lacking
Related Article: CATIE
Phase II Press Release, April 2006
Commonly prescribed antipsychotic medications used to treat Alzheimer's
patients with delusions, aggression, hallucinations, and other similar
symptoms can benefit some patients, but they appear to be no more
effective than a placebo when adverse side effects are considered,
according to the first phase of a large-scale clinical trial funded
by the National Institutes of Health's National Institute of Mental
Health (NIMH).
The trial, known as the Clinical Antipsychotic Trial of Intervention
Effectiveness study for Alzheimer's disease (CATIE-AD),
was published in the October 12, 2006, issue of the New England
Journal of Medicine.
"Antipsychotic medications have been used extensively for
Alzheimer's patients without enough solid evidence of whether they
are effective," said NIMH
Director Thomas R. Insel, M.D. "The study has vital public
health implications because it provides physicians and patients
with information to more accurately weigh the medications' benefits
against their drawbacks, with the needs and unique reactions of
their individual patients."
The $16.9 million, five-year trial was conducted at 42 sites and
included 421 people. Participants had Alzheimer's-related dementia
with additional symptoms such as delusions, aggression, hallucinations,
or agitation that were severe enough to disrupt their functioning.
The study was aimed at patients who either lived with a family member
or caregiver at home, or resided in assisted living facilities,
and excluded patients who had already been confined to a nursing
home. An essential component of the trial was caregiver participation.
He or she provided input to the study doctors on the patient's progress
and reactions to the medication.
In this first phase of the trial, patients were randomized to olanzapine
(Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) —
all newer antipsychotic medications — or to an inactive pill
known as a placebo. Lead author Lon Schneider, M.D., of the University
of Southern California Keck School of Medicine and colleagues judged
each medication's overall benefits and risks by measuring how long
a patient stayed on the medication before discontinuing for any
reason. On average, patients discontinued their medication after
about eight weeks, regardless of whether they were taking an active
medication or placebo, indicating no significant differences in
effectiveness between the active medications and placebo.
Some participants did benefit from the treatment; 26 to 32 percent
of those taking the active medications improved, compared to 21
percent of those taking placebo. But the antipsychotic medications
also were more often associated with troubling side effects, such
as sedation, confusion, and weight gain, compared to placebo. Fifteen
to 24 percent of those taking active medications discontinued use
because of side effects, while only 5 percent of those taking placebo
discontinued use citing side effects.
The study investigators determined the medications' effectiveness
by balancing their associated benefits with their associated risks.
"The antipsychotic medications may be effective against some
symptoms in Alzheimer's patients compared to placebo, but their
tendency to cause intolerable adverse side effects in this vulnerable
population offsets their benefits," concluded Schneider.
Those who discontinued their medications in Phase 1 — 82
percent — went on to subsequent phases of the CATIE-AD
trial in which they were randomized to one of the other study medications
that they had not yet taken, or to citalopram, an antidepressant
medication. Results of these phases are being analyzed and will
be published later.
The flexible design and implementation of the CATIE-AD
trial reflects real-world practices, in which newer antipsychotic
medications often are used to treat delusions, aggression, hallucinations,
and agitation in Alzheimer's patients. Study physicians determined
medication dosage levels according to their patients' individual
needs, and consulted with the patient and caregivers when determining
if and when a patient should discontinue. Patients represented a
broad range of ages (average age was 80 years), diversity, level
of disability and cognitive difficulties.
"In many cases, the moderate to severe thinking and behavioral
symptoms of Alzheimer's precipitate placement in a nursing home,
at which point the economic and social costs associated with Alzheimer's
care skyrocket," said co-lead author Pierre Tariot, M.D., of
the Banner Alzheimer's Institute in Phoenix, AZ. "By identifying
the limitations of existing treatment options, this study is an
important step toward finding a treatment that can delay full-time
nursing home confinements, and reduce the suffering of patients
and their families."
Information on Alzheimer's disease is available from the Alzheimer's
Disease Education and Referral (ADEAR)
Center, sponsored by the NIH's National Institute on Aging. The
Center has information on signs and symptoms of Alzheimer's disease
and lists ongoing clinical trials. Visit the ADEAR
Center website or call 1-800-438-4380 for more information.
The National Institute of Mental Health (NIMH)
mission is to reduce the burden of mental and behavioral disorders
through research on mind, brain, and behavior. More information
is available at the NIMH
website.
The National Institutes of Health (NIH)
— The Nation's Medical Research Agency — includes 27
Institutes and Centers and is a component of the U. S. Department
of Health and Human Services. It is the primary federal agency for
conducting and supporting basic, clinical, and translational medical
research, and it investigates the causes, treatments, and cures
for both common and rare diseases. For more information about NIH
and its programs, visit the NIH
website.
References
Schneider L, Tariot P, Dagerman K, Davis S, Hsiao J, Ismail MS,
Lebowitz B, Lyketsos C, Ryan M, Stroup TS, Sultzer D, Weintraub
D, Lieberman J. Effectiveness of Atypical Antipsychotic Drugs in
Patients with Alzheimer's Disease. New England Journal of Medicine.
2006; 355:1525-38.
Schneider L, Tariot PN, Lyketsos CG, et al. NIMH Clinical Antipsychotic
Trials of Intervention Effectiveness (CATIE): Alzheimer disease
trial methodology. American Journal of Geriatric Psychiatry 2001;
9: 346-60.
Related Information
Questions
and Answers About the NIMH Clinical Antipsychotic Trials of Intervention
Effectiveness (CATIE) Alzheimer’s Disease Study – Phase
I Results
NIMH
Perspective on Treating Alzheimer's Patients with Antipsychotic
Medications
Older
Adults and Mental Health
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