Volunteers Needed Nationwide For Latest Drug, Caregiver And Brain Stimulation Studies For Alzheimer’s, Dementia

The nation’s lead government agency for Alzheimer’s research is looking for a few good men and women. The National Institute on Aging (NIA) is reaching out across the country to find individuals interested in volunteering for research on Alzheimer’s, related dementias and cognitive health, including drug, caregiver and brain stimulation studies.

The NIA funds Alzheimer’s Disease Research Centers (ADRCs) at major medical institutions across the United States, and researchers at these centers are working hard to turn research advances into improved diagnosis, treatment or possibly a cure for Alzheimer’s and other types of dementia. But they can’t do it without volunteers.

For patients and families affected by Alzheimer’s disease, the ADRCs offer help with diagnosis and medical management; information about the disease, services and resources; opportunities for volunteers to participate in clinical trials and studies and patient registries; and support groups and other special programs for volunteers and their families.

In addition, the U.S. Congress created the Alzheimer’s Disease Education and Referral (ADEAR) Center in 1990 to “compile, archive, and disseminate information concerning Alzheimer’s disease” for everyone. Reflecting its expanding focus on related dementias, the ADEAR Center updated its name to “Alzheimer’s and related Dementias Education and Referral Center” (still known as ADEAR) in 2016. The ADEAR Center is a service of the NIA, one of the Federal Government’s National Institutes of Health and part of the U.S. Department of Health and Human Services.

Among NIA’s featured trials and studies—and there are many—are the following:

A new clinical trial on Deep Brain Stimulation (DBS) continuing through October 1, 2024 will test deep brain stimulation (DBS) of the fornix—a major pathway in the brain’s memory circuit that is one of the first areas affected by Alzheimer’s disease—as a treatment for people 65 and older with mild Alzheimer’s disease. The fornix connects the part of the brain that controls memory—the hippocampus—with other areas of the brain.

Caregivers can also participate in NIA studies including the Adult Day Plus Program for Family Caregivers in Baltimore, Maryland and Minneapolis, Minnesota, or the Sleep Intervention for People with Alzheimer’s Disease and their Caregivers in Los Angeles and North Hills, California.

The NIA is also studying both drug and non-drug interventions at sites all over the country on people of all ages. The following is just a sampling:

  • AL001 for Frontotemporal Dementia (multiple sites) This Phase II study is evaluating the safety and tolerability of AL001, a drug being tested in participants with frontotemporal dementia caused by a genetic mutations. Research participants ages 18 to 80 take the study drug, administered intravenously, every 4 weeks for up to 48 weeks. Researchers then measure the concentration of the drug in the blood at specified time points, as well as the drug’s effects on biomarkers of neurodegeneration and on cognition.
  • Montelukast Therapy for Alzheimer’s Disease This clinical trial will test the asthma drug Montelukast, breathing difficulties during exercise and allergic rhinitis, in people with mild cognitive impairment and early Alzheimer’s dementia. Researchers will look for adverse effects as well as changes in memory and other cognitive functions and Alzheimer’s biomarkers on participants who are randomly assigned either the study drug or a placebo. According to the NIA, past studies have shown that Montelukast has a positive effect against inflammatory processes in the brain and on neuronal injury, blood-brain-barrier integrity and beta-amyloid-42 accumulation, however its effects on memory and thinking abilities and on Alzheimer’s biomarkers have yet to be fully understood.
  • Safety and Tolerability of PNT001 in Healthy Adults This Phase I clinical trial will evaluate the safety and tolerability of PNT001—an antibody designed to stop the spread of a specific form of abnormal tau—in healthy adults ages 21 to 65 years. Tau is a protein that forms harmful neurofibrillary tangles in the brains of people with Alzheimer’s disease.

A nondrug intervention study out of the University of Maryland in Baltimore—the Dental Carotid Cognitive Study—examines the effects of intensive therapy for periodontal disease on cognition in high-risk older people with Asymptomatic Carotid Artery Stenosis (ACAS). Several conditions, such as atherosclerosis and diabetes are common in older people with mild to moderate cognitive impairment (MCI), and periodontal disease—an infection of tissues that hold teeth in place—has been associated with these conditions. Individuals with periodontal disease are prone to poor oral hygiene and dental health, which, if untreated, worsens inflammation-mediated brain and nervous system function and accelerates progression to dementia. According to the NIA, ACAS may have a strong association with MCI. This pilot study for people ages 60 to 100 examines the hypothesis that intensive treatment of periodontal disease in older people with MCI and ACAS will lessen their cognitive decline by reducing oral microbial-mediated inflammation that contributes to dementia.

According to the NIA, there are many reasons people get involved in Alzheimer’s and dementia clinical trials. They might include:

  • A desire to help others, including future family members, who may be at risk for Alzheimer’s disease or a related dementia.
  • To receive regular monitoring by medical professionals.
  • To learn about Alzheimer’s and dementia and how it affects overall health.
  • To help test new treatments that might work better than those currently available.
  • To get information about support groups and resources.

Whatever the reason, the NIA encourages anyone who is interested to ask their own doctor, who may know about available local research studies. Other ways to participate include:

The NIA reminds anyone considering participating in a clinical trial or study that while there are benefits of doing so, there are also risks. While researchers make every effort to ensure participants’ safety, all clinical trials have some risk. The research team on each individual study can inform participants about possible side effects or other risks, however.

The NIA also admits that “single clinical trials and studies generally do not have miraculous results, and participants may not benefit directly. With a complex disease like Alzheimer’s, it is unlikely that one drug will cure or prevent the disease.”

Because clinical trials and studies can last days to years and usually require multiple visits to study sites, such as private research facilities, teaching hospitals, Alzheimer’s research centers, or doctors’ offices, some studies pay participants a fee and/or reimburse travel expenses.

Researchers for individual studies screen volunteers to make sure they meet a study’s criteria. And inclusion criteria might include age, stage of dementia, gender, genetic profile, family history and whether or not you have someone to accompany you to appointments. Conversely, exclusion criteria might include specific health conditions or medications that could interfere with the treatment being tested.

Individuals and organizations can also make donations and bequests to the NIA to be used specifically for Alzheimer’s disease research.

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