Age Associated Memory Impairment (AAMI)
- An age-related condition
of undefined etiology that leads to a slow decline in
cognitive ability. AAMI, also referred to as Age Associated
Cognitive Decline, is not associated with a definable
disease state but occurs in up to 50% of people over
the age of 65.
AIDS dementia complex
- Severe neurological damage
associated with AIDS. Symptoms include memory loss,
loss of motor control and behavioral abnormalities.
- A neurodegenerative disease
caused by the loss of neurons in the brain responsible
for learning and memory. AD can cause progressive loss
of memory, the ability to communicate, time and space
orientation and abstract thinking skills.
Apolipoprotein E (ApoE)
- Protein subunit of chylomicrons
that transport cholesterol and fatty acids through the
bloodstream. Alterations of this protein affect the
binding and release of fatty acids and cholesterol,
especially at the site of lipoprotein lipase at the
blood brain barrier. One gene variant, ApoE4, is considered
a genetic risk factor for AD. Approximately 50% of diagnosed
AD patients are ApoE4+ and have an alteration of their
chylomicrons that causes fatty acids and cholesterol
to be more tightly bound and less available for the
- A fiberlike extension
of a neuron by which it sends information to nearby
- Area of the brain where
higher mental functions take place, for example, perceptions,
emotions, thoughts and judgment. Much of the damage
in the brain of AD patients is found here.
- Phase I:
Safety This is the first step in a clinical development
program for a new product candidate. A Phase I
clinical trial is designed to assess the safety
of a product and establish a safe dosing range
for future trials. Such studies utilize groups
of between 20 and 80 healthy volunteers for periods
of a day to several months, depending upon the
recommendations of the FDA.
- Phase II:
Safety and Efficacy Phase II studies are often performed
at various dose levels to determine the efficacy
of a product in treating a specific disease or
medical condition. Although safety is monitored
in a Phase II study there is an emphasis on testing
the therapeutic effect of a product on patients.
These trials involve 20 to about 500 individuals
in each study. Since multiple studies are often
required by regulatory agencies the total number
of patients studied in Phase II often exceeds 1,000.
- Phase III:
Controlled Safety and Efficacy Phase III studies arae
designed to confirm product efficacy in larger
patient populations and to continue to monitor
for rare but significant side effects. These trials
involve several hundred to about 3,000 individuals
depending on the product and disease. Phase III
studies are often designed to compare a product
to other treatment options or in combination with
other therapeutic approaches.
- Brain processes associated
with awareness of perception, reasoning, judgment, intuition,
and memory. The mental process by which knowledge is
- The loss of cognition
that usually is progressive. It interferes with normal
social and occupational activities and leads to disorientation,
impaired memory, judgment and emotions.
- A neurological disorder
characterized by repeated seizures which are caused
by abnormal excitation of large groups of neurons in
the cerebral cortex or the limbic system.
Familial AD (early onset)
- A rare form of AD, affecting
less than 10 percent of AD patients. All FAD is early-onset,
meaning the disease develops before age 65. It is caused
by gene mutations on chromosomes 1, 14, and 21. Even
if one of these mutated genes is inherited from a parent,
the person will almost always develop early-onset AD.
- Cells in the brain and
nerves that are not neurons but support them by helping
to regulate their environment or facilitate impulse
- Part of the brain first
affected by AD and associated with memory formation,
emotion and spatial learning.
- A group of brain structures
including the amygdala, hippocampus, septum, basal ganglia
and others that help regulate the expression of emotion
and emotional memory.
- A Medical Food is an FDA-regulated
product, in a relatively new category of medical protocols
defined by Congress as part of the Orphan Drug Act.
A Medical Food is formulated to be consumed or administered
enterally under the supervision of a physician and is
intended for the specific dietary management of a disease
or condition for which distinctive nutritional requirements,
based on recognized scientific principles, are established
by medical evaluation. Medical Foods can be prescription
products, but are different than drugs or dietary supplements
(also called nutraceuticals) in several aspects, such
as their claims. Claims for both Medical Foods and drugs
must be supported by solid laboratory and clinical data.
Medical Food ingredients have Generally Recognized As
Safe (GRAS) designation, the highest FDA standard of
safety given to foods. Medical Foods, sometimes prescribed
in addition to drugs, nonetheless represent an entirely
different scientific and medical approach to managing
Mild cognitive impairment (MCI)
- Impairment of areas of
the brain that process memory and language, and maintain
attention and focus. While memory and cognition are
impaired these deficits are not severe enough to be
considered dementia. Approximately 70% of patients with
MCI develop AD within 10 years. Generally MCI patients
demonstrate the same risk factors as AD patients. Nearly
8 million Americans suffer from MCI.
- An organelle or rod-like
structure within all cells in the human body whose primary
function is to generate energy, e.g., ATP. Mitochondria
are also involved in protein synthesis and lipid metabolism.
- Progressive damage or
death of neurons leading to a gradual deterioration
of the bodily functions controlled by the affected part
of the nervous system.
- Nerve cell in the brain
whose primary function is to assist in the memory process.
They are characterized by long fibrous projections called
axons and shorter, branch-like projections called dendrites.
Neuronal cells are highly evolved such that they are
restricted in the range of energy substrates that they
can utilize. They prefer ketone bodies but also utilize
glucose or lactate when available.
- Neuronal cell energy metabolism
that requires a narrow spectrum of energy substrates
to fuel basic biochemical, physiological and functional
activities of the cell. Disruption or unavailability
of these energy sources and/or a defect in energy-bearing
metabolic pathways initiates a cascade of neurodegenerative
processes in the brain.
- Healthcare strategy designed
to relieve or lessen the symptoms of diseases for which
there is no cure. AD drugs on the market today provide
only palliative therapeutic activity.
- Neurodegenerative illness
caused by injury or death of the dopamine producing
neurons in a region of the brain known as the substantia
nigra. Symptoms include stooped posture, rhythmic tremors,
slowness of voluntary movement and muscle rigidity.
PET (positron emission tomography)
- An imaging process like
MRI or CT, that provides specific information about
brain activity and structure that has been used to assist
in the diagnosis of AD and track its progression, especially
the loss of energy metabolism in those areas of the
brain affected by the disease.
- Prior to human clinical
testing a potential product is evaluated in laboratory
and animal studies to determine its' safety and biological
Sporadic AD (also, late-onset AD)
- The most common form of
AD believed to be caused by a combination of environmental
and genetic factors, e.g., Apo E4+ genotype. Nearly
90% of all diagnosed AD patients have the sporadic form
of the disease.
- The contact junction where
two neurons transfer information. It is formed by a
space in the cleft where a neurotransmitter is released
and a receptor receives the neurotransmitter thereby
allowing it to exert its action.