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.

Alzheimer's disease

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 brain.

Axons

A fiberlike extension of a neuron by which it sends information to nearby target cells.

Cerebral cortex

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.

Clinical Trials

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.

Cognition

Brain processes associated with awareness of perception, reasoning, judgment, intuition, and memory. The mental process by which knowledge is acquired.

Dementia

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.

Epilepsy

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.

Glia

Cells in the brain and nerves that are not neurons but support them by helping to regulate their environment or facilitate impulse conduction.

Hippocampus

Part of the brain first affected by AD and associated with memory formation, emotion and spatial learning.

Limbic system

A group of brain structures including the amygdala, hippocampus, septum, basal ganglia and others that help regulate the expression of emotion and emotional memory.

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.

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Mitochondria

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.

Neurodegeneration

Progressive damage or death of neurons leading to a gradual deterioration of the bodily functions controlled by the affected part of the nervous system.

Neuron

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.

Neuron energetics

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.

Palliative care

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.

Parkinson's disease

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.

Preclinical Studies

Prior to human clinical testing a potential product is evaluated in laboratory and animal studies to determine its' safety and biological efficacy.

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.

Synapse

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.

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