- Mild Alzheimer’s Disease and Impaired Glucose Tolerance (Jacksonville)
This is a study to evaluate the efficacy and safety of an investigational drug in patients with mild Alzheimer’s disease and impaired glucose tolerance.
Ages Eligible for Study: 50 Years to 85 Years
- Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease
- Mini Mental State Examination (MMSE) score of 21-26, inclusive
- Hemoglobin A1c (HbA1c) 6.5% – 9.5%, inclusive
- Caregiver willing to participate and be able to attend clinic visits with patient
- Ability to ingest oral medications
There are additional criteria to meet in order to qualify for this research study. For more information contact us!
Study Location: Jacksonville
“It is only through clinical studies that we will develop and test promising new strategies for treatment, prevention, diagnosis, and ultimately a cure for Alzheimer’s disease”. (Alzheimer’s Association)
If you or someone you know is concerned about memory loss or Alzheimer’s disease, you may be eligible for one of our clinical research studies. No cost, and no health insurance is required to participate.
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- More Information About Alzheimer’s Disease
- Dementia Related to Over-the-counter Medications
Alzheimer’s disease is a degenerative brain disorder that was first described in 1906 by Dr. Alois Alzheimer. Since that time, Alzheimer’s disease has become the most common cause of dementia (accounting for 60-80% of cases). It is estimated that in 2016, 5.4 million American’s of all ages have Alzheimer’s disease. One in nine people age 65 and older has Alzheimer’s. JCCR has participated as a research center in clinical trials over the past several years to limit the devastating consequences of this difficult to treat disease.
The number of Americans with Alzheimer’s is anticipated to escalate rapidly with the aging of our population, with estimates ranging from 13.8 million to 16 million by 2050. This estimate assumes no medical breakthroughs to prevent or cure the disease.
Alzheimer’s is a slowly progressive brain disease that begins well before clinical symptoms emerge. The persistent accumulation of abnormal proteins in the brain lead to death of brain cells over time, which causes decline in cognitive function. Thus, a significant amount of protein accumulates in the brain over many years before a sufficient amount of brain injury has occurred to cause symptoms noticed by the patient or family/friends.
The medications currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s temporarily improve symptoms by increasing the amount of specific neurotransmitters in the brain. However, they do not address the accumulation of abnormal proteins or brain cell injury and, thus, do not treat the underlying cause of the disease. The first medication approved by the FDA for the treatment of Alzheimer’s was donepezil in 1996. The last was memantine in 2003. There have been no new/novel treatments approved by the FDA for the treatment of Alzheimer’s since 2003. From 2002-2012, 244 drugs for Alzheimer’s were tested in clinical trials, and only one went on to receive FDA approval.
Currently, a worldwide quest is underway to find new treatments to stop, slow or even prevent Alzheimer’s. The last 10-years have seen tremendous growth in research on early detection, and researchers believe that early detection will be key in preventing, slowing and stopping the disease. There is a new wave of optimism in the scientific community about Alzheimer’s treatments.
As eloquently stated by Bill Thies, PhD, Senior Scientist in Residence with the Alzheimer’s Association: “Despite increasing momentum in Alzheimer’s research, we still have two main obstacles to overcome. First, we need volunteers for clinical trials. Volunteering to participate in a study is one of the greatest ways someone can help move Alzheimer’s research forward. Second, we need a significant increase in federal research funding. Investing in research now will cost our nation far less than the cost of care for the rising number of Americans who will be affected by Alzheimer’s in the coming decades.”
Here at JCCR, we understand the importance of recognizing cognitive decline and identifying Alzheimer’s in its early stages. Recent scientific breakthroughs provide hope that new treatments can prevent accumulation of abnormal proteins in the brain and markedly slow the disease. We want to help individuals and their healthcare providers identify the early signs of memory changes so that effective interventions can be initiated promptly. We want to help individuals maintain their memory function and their independence. We also want to facilitate participation in clinical trials that will help our understanding of memory disorders and lead to treatments that will help maintain memory function. We look forward to working with you and your healthcare providers.
Erin G. Doty, MD
Neurologist, Board Certified
Memory issues occur commonly and when they begin, one may worry about the onset of Alzheimer’s disease. While Alzheimer’s may cause memory loss, memory loss is also a symptom of many reversible conditions. Early memory testing is crucial to determine the cause of memory loss to help reverse it before it becomes permanent.
For example, certain over-the-counter medications have been associated with dementia. A recent study came out this month linking Benadryl to dementia. Benadryl has many uses, including allergy symptom relief. The active ingredient in Benadryl is diphenhydramine. This drug blocks the action of acetylcholine (anticholinergic effect) and is used as a sedative because it causes drowsiness. Diphenhydramine is used in most over-the-counter sleeping pills, for motion sickness, and other allergy medications.
A study completed in 2015 at the University of Washington showed the longer and more consistently people took anticholinergics, the more likely they were to develop dementia. Other drugs that contain anticholinergics are used to treat diseases like asthma, incontinence, gastrointestinal cramps, and muscular spasms. They are also prescribed for depression and sleep disorders.
While we do not fully understand dementia, we do know that the neurotransmitter acetylcholine is important in brain processing and memory. We know that the acteylcholinesterase inhibitors (drugs like Aricept (donepezil), Exelon (rivastigmine) and Razadyne (galantamine) which inhibit the breakdown of acetylcholine, do provide symptomatic improvement in affected patients.
It would seem that taking a combination of acetylcholinesterase (cholinergic) with an anticholinergic drug (such as Benadryl) is probably not a good idea. In fact a recent study showed 16% of Alzheimer’s patients living independently were doing just that.
This 2015 study is backed up by another study that came out this month offering the most definitive proof yet, that anticholinergic drugs are linked with cognitive impairment and increased risk of dementia. Using brain imaging they found that patients taking anticholinergic drugs indeed had lower metabolisms and reduced brain sizes.
The bottom line is that given all the research evidence, you should be aware that these over-the-counter medicines may reduce the effectiveness of your prescription medicines. If you or a loved is worried about memory loss, the first step is to get tested to see if it’s from a treatable or reversible cause. Jacksonville Center for Clinical Research offers a professional memory screening for no cost to you. Make an appointment today to help put your mind at ease.
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