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Old 06-07-2007, 07:47 PM #1
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jeanb jeanb is offline
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jeanb jeanb is offline
Senior Member
jeanb's Avatar
 
Join Date: Aug 2006
Location: sonoran desert
Posts: 1,352
15 yr Member
Book cogane phase II Alzheimer's trial results

(emphasis is mine)


From Phytopharm 2006 annual report:


In late November 2005 we announced the
preliminary results obtained from the Phase IIa
clinical study of Cogane™ in mild and moderate
Alzheimer’s disease patients. The Oxford Project to
Investigate Memory and Ageing (OPTIMA) was the
lead clinical centre and 15 other sites in the UK


Two hundred and fifty-six subjects with Alzheimer’s
disease ranging in severity from mild to moderate
were randomly allocated to receive either 120 mg
Cogane™ (n = 127) or a placebo (n = 129), orally
once daily for 12 weeks. The majority of patients
enrolled had mild disease. The baseline
demography data confirmed that the treatment
groups were well balanced for factors such as age,
gender and severity of disease.

The overall safety data confirmed that Cogane™
administered orally once daily for up to 12 weeks is
well tolerated and has a good overall clinical safety
profile. There were no substantial differences in the
adverse event and laboratory safety data for
each group.

The prospectively defined primary efficacy
measures were cognitive assessments measured
using CANTAB-PAL and the Hopkins verbal learning
test. The baseline scores and changes over time
were not significantly different between the groups.
Although the Phase IIa clinical trial was not of a
sufficient duration to observe deterioration in
cognitive function in the group of Alzheimer’s
patients whose disease severity included both mild
and moderate disease, a subset analysis on the
smaller number of patients with moderate
Alzheimer’s disease showed a trend towards
deterioration in the placebo group, with no
significant deterioration observed in the Cogane™
group.

This encouraging trend for slower disease
progression in more moderate Alzheimer’s patients
with Cogane™ coupled with its excellent tolerability,
confirms the need for longer term studies for
efficacy determination. Further work has now been
initiated in preparation for further clinical studies
and discussions with potentially suitable licensees
have progressed to detailed evaluations and due
diligence assessments of the full data set.
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This isn't the life I wished for, but it is the life I have. So I'm doing my best.
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