thanks, also note "A more complete set of results will be available at
the time of the conference." here's the relevant stuff:
Background:
Despite major efforts aimed at finding a treatment for
Alzheimer’s disease (AD), progress in developing compounds that can
relieve cognitive deficits associated with the disease has been slow.
ANAVEX 2-73 is a sigma-1 and muscarinic receptor agonist that in
preclinical studies has shown memory-preserving and neuroprotective
effects. In our ongoing phase 2a clinical study we are assessing
ANAVEX 2-73 safety in subjects with mild-to-moderated AD, and
measuring drug effects on MMSE, EEG and Event Related Potentials
(ERP) cognitive measures, and Cogstate test batteries to optimize
dosing.
Methods:
Thirty-two subjects that meet NINCDS-ADRDA
criteria for probable AD are being recruited at up to seven clinical sites
in Melbourne, Australia. Subjects are between 55 and 85 years of age,
and have an MMSE of 16 to 28. In PART A of the study, participants
are administered ANAVEX 2-73 orally and IV in an open-label,
2-period, cross-over trial with adaptive study design lasting up to 36
days for each participant. In PART B of the study, all participants are
administered ANAVEX 2-73 daily orally. MMSE, EEG/ERP (P300)
and Cogstate tests are performed at baseline and subsequently at
weeks 12, 26, 38 and 52 of the PART B open label extension.
Results:
The primary outcome of the study is safety, and ANAVEX 2-73
was well tolerated. In the secondary outcome endpoints preliminary
analysis of data from subjects to date shows an average improvement
of the MMSE score at week 12 in PART B (week 17 from baseline).
A significant majority of all patients tested so far improved their
respective MMSE score. The average EEG/ERP (P300 amplitude)
signal also improved and also the average Cogstate test improved
across the test batteries.
Conclusions:
Data collected so far indicate
that ANAVEX 2-73 is safe and well tolerated. Interim results also
show improved cognitive performance after drug administration in
subjects with mild-to-moderate AD. The current results seem to justify
a prospective comparison with current standard of care in a larger clinical trial study. A more complete set of results will be available at
the time of the conference
the time of the conference." here's the relevant stuff:
Background:
Despite major efforts aimed at finding a treatment for
Alzheimer’s disease (AD), progress in developing compounds that can
relieve cognitive deficits associated with the disease has been slow.
ANAVEX 2-73 is a sigma-1 and muscarinic receptor agonist that in
preclinical studies has shown memory-preserving and neuroprotective
effects. In our ongoing phase 2a clinical study we are assessing
ANAVEX 2-73 safety in subjects with mild-to-moderated AD, and
measuring drug effects on MMSE, EEG and Event Related Potentials
(ERP) cognitive measures, and Cogstate test batteries to optimize
dosing.
Methods:
Thirty-two subjects that meet NINCDS-ADRDA
criteria for probable AD are being recruited at up to seven clinical sites
in Melbourne, Australia. Subjects are between 55 and 85 years of age,
and have an MMSE of 16 to 28. In PART A of the study, participants
are administered ANAVEX 2-73 orally and IV in an open-label,
2-period, cross-over trial with adaptive study design lasting up to 36
days for each participant. In PART B of the study, all participants are
administered ANAVEX 2-73 daily orally. MMSE, EEG/ERP (P300)
and Cogstate tests are performed at baseline and subsequently at
weeks 12, 26, 38 and 52 of the PART B open label extension.
Results:
The primary outcome of the study is safety, and ANAVEX 2-73
was well tolerated. In the secondary outcome endpoints preliminary
analysis of data from subjects to date shows an average improvement
of the MMSE score at week 12 in PART B (week 17 from baseline).
A significant majority of all patients tested so far improved their
respective MMSE score. The average EEG/ERP (P300 amplitude)
signal also improved and also the average Cogstate test improved
across the test batteries.
Conclusions:
Data collected so far indicate
that ANAVEX 2-73 is safe and well tolerated. Interim results also
show improved cognitive performance after drug administration in
subjects with mild-to-moderate AD. The current results seem to justify
a prospective comparison with current standard of care in a larger clinical trial study. A more complete set of results will be available at
the time of the conference
