Alzheimer's, Dementia & Mental Health
Alzheimer’s Patients Show Significant Slowing of
Decline with New Drug
Experimental drug Solanezumab that once got bad
grades in Eli Lilly clinical trial bounces back
Oct. 9, 2012 – The quest for a drug to treat
Alzheimer’s disease continues its bumpy progress as Eli Lilly and
Company announced yesterday that an experimental drug therapy called
solanezumab targeting mild to moderate Alzheimer's disease, that did not
meet their primary endpoints in August, has now produced a
“statistically significant slowing of cognitive decline.” This second
look at the Phase 3 data found the cognitive decline was slowed by 34
"Doctors called the results encouraging, although
probably not good enough to win Food and Drug Administration approval of
the drug without another study to confirm there is a benefit," reports
The New York Times.
This announcement followed the presentation of
results from independent analyses of the EXPEDITION study data conducted
by the Alzheimer's Disease Cooperative Study (ADCS), an academic
research consortium, at the annual meeting of the American Neurological
The presentation was by
Rachelle Doody, M.D., Ph.D., professor of Neurology and the Effie
Marie Cain Chair in Alzheimer's Disease Research,
Baylor College of Medicine, who is also a member of the steering
committee for the ADCS.
"Alzheimer's disease research has been extremely
challenging," said Dr. Doody. "The data results from the solanezumab
Phase 3 trials were encouraging to the ADCS team. These results
represent an important step for the medical, academic, and scientific
communities in understanding brain amyloid as a target of AD therapies."
The Alzheimer’s Association had noted in a
statement issued on August 24 that solanezumab was not out of the race
for a treatment drug.
“… there is new and encouraging information here.
According to the company, in a secondary pooled analysis of both
studies, the drug at the tested dose showed a statistically significant
slowing of cognitive decline in people with mild to moderate Alzheimer's
disease; the results were driven by people with mild Alzheimer's,” said
the association’s statement.
“If this finding can be duplicated, it suggests
that an Alzheimer's therapy targeting beta amyloid can have a beneficial
effect on cognitive abilities in people with mild to moderate
Alzheimer's. That would be a major step forward in the fight against
Lilly provided the raw data (the full data set
collected from the EXPEDITION studies) to the ADCS. The ADCS
statisticians then performed independent analyses of these data. These
results were presented at the meeting.
"This is a complex disease that touches millions of
people worldwide," said David Ricks,
senior vice president and president, Lilly Bio-Medicines. "Alzheimer's
disease causes significant burden on patients, caregivers and our
society. While the path forward has not been determined, we believe
these data in patients with mild disease may provide a step toward a
potential treatment option."
Following is the report on the studies by Lilly.
Results from EXPEDITION1
The EXPEDITION1 study was
designed with co-primary cognitive and functional endpoints (the
Alzheimer's Disease Assessment Scale- Cognitive subscale and the
Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL],
respectively) in patients with mild-to-moderate Alzeimer's disease.
secondary analyses showed that results in patients with mild Alzheimer's
disease taking solanezumab demonstrated a slowing of cognitive decline
compared with placebo, as measured by the scale. This finding
represented a 42 percent reduction in decline at the endpoint of the
18-month study. The difference in functional decline (ADCS-ADL) was not
Results from EXPEDITION2
Based on the results of
EXPEDITION1, Lilly says it modified the statistical analysis plan (SAP)
for EXPEDITION2, prior to database lock, to specify a single primary
endpoint of cognition in patients with mild Alzheimer's disease as
measured by the ADAS-Cog14, a 14-item scale, which includes three
additional items considered relevant for patients with mild Alzheimer's
disease.1 At the conclusion of EXPEDITION2, there was a 20 percent
reduction in cognitive decline in patients with mild Alzheimer's disease
taking solanezumab; however, the treatment difference was not
statistically significant (p=.120). In the pre-specified secondary
endpoint of ADCS-ADL, there was a 19 percent reduction in functional
decline in patients with mild Alzheimer's disease treated with
solanezumab, as compared with placebo; this difference was not
statistically significant (p=.076).
Results from Pooled Analyses of EXPEDITION1 and EXPEDITION2
A pre-specified secondary
analysis of pooled data in patients with mild Alzheimer's disease showed
a slowing of cognitive decline (p=.001) compared with placebo, as
measured by the ADAS-Cog14; this finding represented a 34 percent
reduction in decline. In addition, the secondary analysis of the pooled
data in patients with mild Alzheimer's disease showed a 17 percent
reduction of functional decline as measured by the ADCS-ADL; however,
the treatment difference was not statistically significant compared with
A number of different
biomarkers were assessed in the EXPEDITION studies. Some, but not all,
of these biomarkers showed an effect of solanezumab. These additional
data will be presented by the ADCS at the Clinical Trials on Alzheimer's
Disease (CTAD) meeting in Monte Carlo, Monaco,
on October 29, 2012, or at subsequent
medical meetings and in appropriate scientific venues.
In the EXPEDITION studies,
the only adverse event with an incidence of at least 1 percent that
occurred statistically significantly more in the solanezumab group than
in the placebo group was angina (1.1 percent versus 0.2 percent). The
incidence of vasogenic edema (ARIA-E) was approximately 1 percent,
occurring in 11 patients treated with solanezumab and 5 patients on
placebo, which was not statistically significant.
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