Clinical Trials for Alzheimer’s Disease

What is Alzheimer’s Disease?

Alzheimer’s disease is a progressive brain disease caused by a combination of genetic, environmental, and lifestyle factors including diet and nutrition. It is characterized by specific changes in the brain – including amyloid plaques and neurofibrillary, or tau, tangles which are clumps of protein – that result in loss of neurons and their connections.

What are some current treatment options for Alzheimer’s disease?

Cholinesterase inhibitors (Donepezil, Galantamine, Rivastigmine)

One way Alzheimer’s disease harms the brain is by decreasing levels of a chemical messenger (acetylcholine) that is important for alertness, memory, thought and judgement. Cholinesterase inhibitors boost the amount of acetylcholine available to nerve cells by preventing its breakdown in the brain

Memantine

Memantine is approved by the FDA for treatment of moderate-severe Alzheimer’s disease. It works by regulating the activity of glutamate, a messenger chemical widely involved in brain functions – including learning and memory.

Why are Clinical Trials Useful in Alzheimer’s Disease?

Clinical trials for Alzheimer's disease play a crucial role in advancing our understanding of the disease, developing new treatments, and improving the quality of life for affected individuals.

Understanding the Disease Better: Alzheimer's disease is a complex and poorly understood neurodegenerative disorder. Clinical trials help researchers gain insights into the disease's underlying mechanisms, its progression, and how it affects the brain. This knowledge is essential for developing effective interventions.

Developing and Testing New Treatments: Clinical trials provide a platform for testing potential treatments, including medications, therapies, and interventions, that could slow down, halt, or even reverse the progression of Alzheimer's. These trials are necessary to determine the safety and efficacy of new treatments before they can be approved for widespread use.

What are control groups?

A control group in research is a group of subjects or items in an experiment that is used as a baseline or reference point for comparison with the experimental group. The control group is typically not exposed to the treatment that the researcher is studying.

Why are they important?

Establishing Causation: By using a control group, researchers can compare the outcomes of the experimental group (those receiving a treatment or intervention) with those of the control group (those not receiving the treatment). If there is a significant difference in outcomes between the two groups, it provides evidence that the treatment or intervention caused the observed effect.

Minimizing Bias: Without a control group, researchers may attribute observed changes or effects solely to the intervention being tested when other factors could be responsible. Control groups act as a baseline against which to compare the experimental group, helping to ensure that any observed effects are not simply due to chance or external factors.

New Alzheimer’s Clinical Trials

Bluewater Clinical Research Group is currently recruiting participants for an Alzheimer’s clinical study involving a new oral medication called piromelatine, which acts primarily as an agonist of melatonin and serotonin receptors. Through this unique action, in previous phases, this medication demonstrated neuroprotection, memory enhancement, and sleep promotion. Overall, designed to improve symptoms in patients with mild-moderate Alzheimer’s disease.

Amyloid, a protein that builds up on the brain and causes plaques in Alzheimer’s patients, disrupts cell function. Researchers have explored that accumulation of amyloid plaques is a crucial first step toward the cognitive decline observed in Alzheimer’s disease. In the early new year, Bluewater Clinical Research Group will be enrolling for a new Alzheimer’s clinical study which involves a subcutaneous injection of a medication called remternetug, which targets these plaques deposited in the brain.