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The Search for New Treatments
More and more, scientists are able to think about ways to treat, slow, or
perhaps even prevent AD at a number of possible points during the years-long
continuum of disease progression. This continuum begins with the very earliest
disease stage, even before symptoms are evident, moves to the first signs of
memory and cognitive problems, then continues through the mild and moderate
stages, and ends with the very late stages and the person’s death.
As a result, researchers who focus on developing AD treatments think a lot
about the importance of timing: When would it be best to intervene and
what interventions are most appropriate at which time? These questions are
similar to those asked with other conditions, such as heart disease. For
example, a physician would prescribe different treatments for a patient who is
seemingly healthy but who is at risk of having future heart disease than for a
patient who is actually having a heart attack or whose heart disease is well
established. The same decision process now can be applied to AD.
It has become clear that there probably is no single “magic bullet” that
will, by itself, prevent or cure AD. Therefore, investigators are working to
develop an array of options from which physicians can choose. For people who
already have AD, the most immediate need is for treatments to control cognitive
loss as well as problem behaviors, such as aggression, agitation, wandering,
depression, sleep disturbances, hallucinations, and delusions. Safe medications
that remain effective over time are needed to ease a broad range of symptoms and
to improve a person’s cognitive function and ability to carry out activities
of daily living. Scientists also are investigating treatments that combine
medications with lifestyle strategies to lessen the risk of developing cognitive
decline or AD. Eventually, scientists hope to develop treatments that attack the
earliest manifestations and underlying causes of AD, thereby slowing, delaying,
or preventing the disease from progressing and damaging cognitive function and
quality of life. Scientists use clinical
trials to pursue all these goals.
Today, NIA, other NIH institutes, and private industry are conducting many
clinical trials of AD interventions (see "Participating
in a Clinical Trial" for more about clinical trials). These studies
focus on several key areas:
 | Helping people with AD maintain their mental functioning
| Managing symptoms
| Slowing, delaying, or preventing AD |
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 HELPING
PEOPLE WITH AD MAINTAIN THEIR MENTAL FUNCTIONING
In the mid-1970s, scientists discovered that levels of a neurotransmitter (a
chemical that carries messages between neurons) called acetylcholine fell
sharply in people with AD. This discovery was one of the first that linked AD
with biochemical changes in the brain. Scientists found that acetylcholine is a
critical player in the process of forming memories. It is used by neurons in the
hippocampus and cerebral cortex, which are areas of the brain important to
memory function. This discovery was an important initial breakthrough in the
search for drugs to treat AD.
Four medications, tested in clinical trials, have been approved by the FDA
for use in treating AD symptoms. Donepezil (Aricept®), rivastigmine (Exelon®),
and galantamine (Razadyne®) are prescribed to treat mild to moderate AD
symptoms. Donepezil was recently approved to treat severe AD as well. These
drugs, known as cholinesterase inhibitors, act by stopping or slowing the action
of acetylcholinesterase, an enzyme that breaks down acetylcholine. They help to
maintain higher levels of acetylcholine in the brain. In some people, the drugs
maintain abilities to carry out activities of daily living. They also may
maintain some thinking, memory, or speaking skills, and can help with certain
behavioral symptoms. However, they will not stop or reverse the underlying
progression of AD and appear to help people only for months to a few years. The
newest approved AD medication is memantine (Namenda®), which is prescribed to
treat moderate to severe AD symptoms. This drug appears to work by regulating
levels of glutamate, another neurotransmitter involved in memory function. Like
the cholinesterase inhibitors, memantine will not stop or reverse AD.
MANAGING SYMPTOMS
“My father is often agitated. He paces up and down, wringing his
hands and crying. I know he’s sad or anxious about something but he can’t
tell me what’s bothering him. Asking him about it just makes him more
upset.”
“Last week, I visited Mom in the nursing home. We had a great time.
Then yesterday, I went to see her again. When I walked into her room, she
didn’t know me. She thought I was her sister.”
“My husband used to be such an easy going, calm person. Now, he
suddenly lashes out at me and uses awful language. Last week, he got angry when
our daughter and her family came over and we sat down to eat. I never know when
it’s going to happen. He’s changed so much—it scares me sometimes.”
“Gran hums all the time. She used to be a singer. Is she trying to
relive her past?”
As AD begins to affect memory and mental abilities, it also begins to change
a person’s emotions and behaviors. Between 70 and 90 percent of people with AD
eventually develop one or more behavioral symptoms. These symptoms include
sleeplessness, wandering and pacing, aggression, agitation, anger, depression,
and hallucinations and delusions. Some of these symptoms may become worse in the
evening (a phenomenon called “sundowning”) or during daily routines,
especially bathing.
The damage of AD affects many different parts of the brain. This presents a
problem because even small tasks require the brain to process signals that often
involve more than one region of the brain. If this processing is disrupted
because of AD, the person may not be able to do the task or may act in a strange
or inappropriate way.
In light of our growing understanding about the effects of AD on the brain,
behaviors like the ones highlighted above suddenly make sense or even provide a
loving opportunity for caregivers:
For a man who can no longer distinguish between past and present, the
anguish caused by the death of a parent may be as real today as it was many
years before.
Sitting down to a family meal may produce intense anxiety when a person
has no idea what to do with the knife and fork in front of him and all the
conversation and activity feel overwhelming.
Memories of favorite songs from long ago resurface and provide a
compelling link to a happy time in the past.
Behavioral symptoms, often emotional and upsetting, are one of the hardest
aspects of the disease for families and other caregivers to deal with. They are
also a visible sign of the terrible change that has taken place in the person
with AD. Researchers are slowly learning more about why behavioral symptoms
occur and are conducting clinical trials on new treatments—both drug and
non-drug—to deal with difficult behaviors.
Coping with Behavioral Symptoms
For more information on how to deal with behavioral issues and
symptoms, visit the caregiving section of NIA’s Alzheimer’s
Disease Education and Referral (ADEAR) Center website at: www.nia.nih.gov/Alzheimers/Caregiving/HomeAndFamily.
|
 SLOWING,
DELAYING, OR PREVENTING AD
AD research has developed to the point where scientists are looking beyond
treating symptoms to addressing the underlying disease process. Slowing the
progress of AD could do much to maintain the functioning of people with AD and
reduce physical and emotional stress on caregivers. Delaying AD’s effects also
could help to postpone or prevent placement in an assisted living facility or
nursing home, and reduce the financial costs of the disease. Preventing AD
altogether is, of course, the ultimate long-term goal.
NIA and pharmaceutical companies support treatment clinical trials that are
aimed at slowing, delaying, or preventing AD. The advances in our knowledge
about the mechanisms and risk factors associated with AD have expanded the types
of interventions under study. These trials are examining a host of possible
interventions, including cardiovascular treatments, hormones, type 2 diabetes
treatments, antioxidants, omega-3 fatty acids, immunization, cognitive training,
and exercise, among others.
For example, NIA funds pilot trials to learn whether treating one or another
aspect of type 2 diabetes will affect cognitive health and AD progression. A
pilot trial is a relatively small clinical trial that collects initial data on
the safety, effectiveness, and best dosage of a potential treatment. This
information helps investigators decide which treatments should be tested in
larger, full-scale trials. One 4-month pilot trial has examined the effects on
AD of administering a nasal-spray form of insulin. This trial is founded on
evidence that AD is associated with reduced levels of insulin in cerebrospinal
fluid and that treatment with insulin improves memory performance. The trial
will provide useful data on the safety, feasibility, and potential effectiveness
of this innovative treatment approach. Investigators may be able to use the
results to plan future full-scale clinical trials.
Beyond pilot studies, investigators also are conducting full-scale AD
clinical trials of various interventions. One of these trials, the Alzheimer’s
Disease Cooperative Study (ADCS), is testing whether one omega-3 fatty acid (DHA),
found in the oil of certain fish, can slow the progression of cognitive and
functional decline in people with mild to moderate AD. During the 18-month
clinical trial, investigators will measure the progress of the disease using
standard tests for functional and cognitive change. Researchers also will
evaluate whether taking DHA supplements has a positive effect on possible
physical and biological markers of AD, such as brain atrophy and proteins in
blood and spinal fluid. The ADCS is a federally established consortium
conducting clinical trials on AD, with sites across the United States and
Canada.
 Full-scale
AD prevention trials are under-way as well. One such trial, Prevention of
Alzheimer’s Disease with Vitamin E and Selenium (PREADVISE), is being
conducted in conjunction with a National Cancer Institute-funded trial called
the Selenium and Vitamin E Cancer Prevention Trial (SELECT). SELECT is
evaluating whether taking selenium and/or vitamin E supplements can prevent
prostate cancer in healthy men older than 60 years. PREADVISE is evaluating
whether these supplements can help prevent memory loss and dementia by
protecting brain cells from oxidative damage (see "The
Aging Process" for more on oxidative damage). About 6,000 of the more
than 30,000 men enrolled in SELECT are participating in PREADVISE.
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