|
E-mail this page to a friend!
Alzheimer's, Dementia & Mental Health
Experimental Drug Ketasyn Improves Memory in
Age-Associated Memory Impairment
Earlier found to improve memory for Alzheimer's
patients
Aug. 29, 2007 – Encouraging news about the ability
of Ketasyn (AC-1202) to prompt a positive and meaningful effect on
memory in older adults was released today by Accera, Inc. The results
are from a Phase II study of the company’s lead product in fighting
age-associated memory impairment (AAMI).
In June the company reported on a clinical trial
with Alzheimer’s patients and said Ketasyn proved safe and its ability
to “significantly improve the memory and cognition of subjects.”
AAMI is the decline in memory that occurs during
the natural course of aging. The National Institute of Mental Health
criteria for AAMI include complaints of gradual memory loss in everyday
problems in persons more than 50 years of age.
AAMI affects an estimated 10-15 million people in
the U.S., and may be a precursor to Alzheimer's disease (AD), which is
expected to afflict 11-16 million Americans in the next 40 years.
AAMI symptoms may be related to declines in glucose
metabolism in the brain that are also associated with aging. Glucose is
the brain's primary fuel source, so aging brains with impaired glucose
metabolism require an alternative source of energy.
Ketasyn is an orally available compound that is
metabolized into ketone bodies, which the brain can use for energy even
when its ability to process glucose is impaired.
"The results of this study support the hypothesis
that providing additional energy reserves to the elderly brain improves
a variety of cognitive activities. They also provide further evidence of
the roles that glucose and insulin metabolism plays in cognition and
memory," said Dr. Lauren Costantini, Accera's vice president of clinical
development.
"As in our earlier successful clinical studies in
Alzheimer's disease, Ketasyn was well tolerated by subjects in the AAMI
study and we are encouraged by the strong efficacy data."
The randomized, double-blind, placebo-controlled,
parallel, multi-center trial was conducted at six centers in the United
States. One hundred fifty- nine subjects diagnosed with AAMI received
either Ketasyn or placebo for 90 days followed by a two-week washout
period.
Mean age in this study was 65.
Subjects underwent genomic testing for variations
in the coding regions of genes known to influence memory and cognition,
including the apolipoprotein E gene (APOE), a known genetic risk factor
for Alzheimer's disease (AD) that occurs in 15-20% of the general
population.
On days 0, 30, 60, 90 and 104, subjects were
evaluated through a battery of neuropsychometric tests that measure
various aspects of memory and cognition.
Ketasyn showed significant efficacy in tests of
memory. On average, subjects taking Ketasyn performed significantly
better on the 'First-Last Name Association' test (FLN) than subjects
taking placebo (p=0.042). "On average, seniors taking Ketasyn remembered
more names than those taking placebo," said Dr. Costantini.
In another memory test called Name-Face Recognition
(NFA), which associates a person's name and face, Ketasyn subjects under
age 59 improved significantly more than placebo subjects at Day 90
(p=0.0217). The efficacy in the NFA test observed with Ketasyn in
subjects under age 59 captures a large portion of the AAMI population.
Consistent with the findings of Accera's Phase IIa
and IIb AD studies, subjects who did not have the APOE4 genotype (E4(-))
responded particularly well to treatment: E4(-) subjects showed a
further significant treatment effect of Ketasyn in FLN at Day 90
(p=0.012). In contrast, and also consistent with the AD trial results,
APOE4(+) subjects showed no difference between Ketasyn and placebo for
FLN scores at Day 90 (p=0.4639).
The company reported that the safety profile of
Ketasyn was “excellent,” as shown in the previous AD trials with Ketasyn.
The incidence of adverse events was low and similar between Ketasyn and
placebo groups.
Accera recently completed a Phase IIb clinical
trial in AD patients that confirmed Ketasyn's safety and efficacy as
measured by improvement in ADAS-Cog scores, the gold standard measure
for efficacy in cognition and short-term memory.
Accera plans to initiate a pivotal, Phase III
multi-center clinical trial in early 2008 in mild-to-moderate AD
patients. This study will focus on several measures of efficacy,
including ADAS-Cog, safety and the role of insulin regulation in AD.
About Ketasyn(TM) (AC-1202)
Brain imaging techniques performed on aging adults
and Alzheimer's patients reveal a dramatically decreased uptake of
glucose, the brain's preferred source of energy. Ketasyn(TM) (AC-1202)
is an orally available compound that is efficiently metabolized by the
liver into ketone bodies, an alternative energy source that the brain
can utilize when glucose metabolism is compromised. Ketasyn has disease
modifying potential in AD and a number other neurodegenerative diseases
characterized by decreased glucose use in the brain, which is known as
neuronal hypometabolism.
About Accera, Inc.
Based in Broomfield, CO, Accera, Inc. is a
privately held biotechnology company focused on developing novel drugs
for neurodegenerative diseases. The company's lead candidate, AC-1202,
is a first-in-class molecule that has recently completed Phase II
clinical trials for Alzheimer's disease and Age- Associated Memory
Impairment. Accera has other small molecule compounds in its product
pipeline for a range of other neurodegenerative diseases including
Parkinson's disease and Huntington's disease. For more information,
visit:
http://www.accerapharma.com/.
Click to More Senior News on the
Front Page
Copyright: SeniorJournal.com |
Current early diagnosis is based on study of
patient’s behavior