Neurochem Alzheimer Drug
Phase III Trial Inconclusive
Reporting by Janet Guttsman, editing by Lincoln Feast.
TORONTO, August 26 (Reuters) — Canadian biotech
company Neurochem Inc said on Sunday that a Phase III
clinical trial had not demonstrated a statistically significant
difference in favor of its tramiprosate treatment for
Alzheimer’s disease.
The North American trial for tramiprosate involved
1,052 patients in 67 centers in Canada and the United
States. Patients, who were suffering from mild-to-moderate
Alzheimer’s disease received either a placebo or one of
two doses of the drug, but Neurochem said results were
inconclusive.
“Due to significant interference from high between-site
variations that complicated the statistical analyses beyond
expectations, it is not possible to draw definitive conclusions
with respect to the treatment effect of tramiprosate,” it said.
The Canadian biotech company will discuss results of the
trial, and of its discussions with the U.S. Food and Drug
Administration on a conference call on Monday.
“The agency...advised that neither the proposed adjusted
models nor any further adjustments could be used for this
trial to provide results in support of a claim of clinical
efficacy,” Neurochem said.
Neurochem said last month that the FDA had designated
tramiprosate, or Alzhamed, as a fast-track product, allowing
accelerated review and development. Its shares rose steeply
in response.
The company said it had set up a special advisory board
to analyze data from the trial and consider future options.
It was considering how to modify a European Phase III trial
of the drug.
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Novartis Gets U.S. Approval for Alzheimer Patch
ZURICH, July 9 (Reuters) — Pharmaceutical group Novartis
said on Monday it had received U.S. approval for Exelon
Patch, which delivers a treatment for Alzheimer’s disease
through a skin patch instead of an oral capsule.
The medication was submitted for review in the
European Union in late 2006, Novartis said. The Federal
Food and Drug Administration (FDA) also approved the use
of Exelon Patch in treating patients with mild to moderate
Parkinson’s disease dementia, Novartis said.
The Exelon Patch, which is applied to the back, chest or
upper arm, maintains steady drug levels in the bloodstream,
improving tolerability and allowing a higher proportion of
patients to receive therapeutic doses of medication, with
potential improvements in efficacy,Novartis said.
Alzheimer’s disease is a progressive, degenerative disease
that alters the brain, causing impaired memory, thinking and
behavior. Approximately 18 million people worldwide
have Alzheimer's disease,Novartis said.
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Treating Heart Disease Risk Factors May
Slow Alzheimer's Disease Progression
Late-life weight loss and “motivational reserve” may also affect
Alzheimer's risk
Alzheimer's Association, National
WASHINGTON D.C., June 10, 2007 — A new study
suggests that treating risk factors for heart disease and stroke,
such as high blood pressure and diabetes, may slow the
progression of Alzheimer's disease, according to research
reported today at the 2nd Alzheimer’s Association
International Conference on Prevention of Dementia in
Washington,D.C.
Two new studies presented at the conference further confirm
the close relationship between heart health and brain
health. A third report, this one from the Nun Study, suggests
that unexplained weight changes in late life have an
impact on dementia risk and also may be useful, when
combined with other factors such as biomarkers, as an
indicator for early detection of dementia. Finally, a team of
scientists has developed a new concept called “motivational
reserve,”similar to “cognitive reserve,”that may be related to
incidence and progression of Alzheimer’s.
“The best known and most solid risk factors for
Alzheimer’s are age, family history and genetics, but those
are things you can’t change,” said William Thies, Ph.D., vice
president of Medical and Scientific Relations for the
Alzheimer’s Association. “Research that identifies lifestyle
risk factors gives people actions they can do, and positive
choices they can make, to reduce their risk of Alzheimer’s
— like lowering their blood pressure and treating their
diabetes, or better still avoiding them in the first place.
That’s a good research investment.”
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