Are There Any Clinical Trials For Alzheimer’s

An Interview With Connie Lesko: A Caregiver’s Perspective

Like many families affected by Alzheimers, Connie Lesko and her three siblings knew very little about caregiving when their parents were both diagnosed with Alzheimers at nearly the same time. At first, we were just putting one foot in front of the other, Connie remembered. For eighteen months after the diagnoses, the four siblings alternated spending time looking after their parents. Their disease progressed quickly, however, and the decision was made to move them into an assisted living facility in Sun City Center. The decision came not a second too soon, and the Lesko parents were soon moved to a secured Alzheimers unit after Connies father wandered off on one occasion.

As painful as the experience with her parents was, Connie says she is heartbroken for Alzheimers patients who dont have close family to advocate for them. She shifted her marketing career to focus on the senior living industry, where she has worked for the past fifteen years, including multiple stints at facilities that focus on Alzheimers patients.

My mother couldnt walk, talk, or feed herself by the end of her life, Connie said. No one should have to go through that.

Beyond the personal benefits, Connie believes Alzheimers trials represent a higher purpose for American seniors. Were all citizens of a country where Alzheimers is the sixth leading cause of death. How can we not be a part of the solution?

Determine A Maximum Tolerated Dose In Phase I

Dose escalation studies in Phase I and dose refinement studies in Phase II should provide confidence in the dose selected for Phase III. In particular, it is important to establish a MTD whenever possible to ensure that the highest possible doses have been explored. In some cases, occupancy studies may allow conclusions about dosing without an MTD if the receptor is fully occupied at lower doses. In other situations, solubility or physical features may limit the administered dose and the MTD cannot be determined. Beyond these exceptional circumstances, an MTD should be determined. Without an MTD, failure to show a drug-placebo difference in Phase II or Phase III will raise questions about the adequacy of the dose.

What Are Clinical Research Trials

Clinical research

Before a new drug or treatment can be used to treat a disease, it must first be carefully tested in a laboratory, then with live people, in what is called a clinical research trial, in order to evaluate the effectiveness and safety of the drug or treatment.

There is a protocol that is followed for every clinical trial, designed to answer a specific research question, as well as protecting the safety of the participants in the study. A protocol describes exactly who will participate in the trial, which tests and procedures, medications and dosages will be used, as well as how long the study will last, and what type of information will be collected during the study.

The federal government mandates that all clinical trials are governed closely by an Institutional Review Board – comprised of a committee of physicians, statisticians and members of the community. The IRB is appointed in order to ensure the risks of the clinical trial are minimal and that potential benefits are worth the risks.

What if I dont want to take an Experimental Drug, but I do want to Help Advance Alzheimers research?There are a variety of research studies that aim to assess the effectiveness of things other than drugs, like exercise, dietary changes, or even educational strategies .

Taking part in a research study does not have to mean that a person needs to take an experimental drug, specifically.

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Israeli Revolutionary Alzheimers Treatment To Launch Phase 1 Trial

The Phase I trial will specifically test ImmunoBrain Checkpoints proprietary antibody, IBC-Ab002, which is targeted to enhance the immune system and induce brain repair processes

, September 10, 2020

A novel treatment for Alzheimers, developed by one of Israels top scientists, is preparing to launch a Phase 1 clinical trial and, if successful, it could change the course of the disease and arrest its progression.

The therapy, developed by ImmunoBrain Checkpoint and based on 20 years of work by Prof. Michal Schwartz of the Weizmann Institute of Science demonstrating that the immune system is needed for the maintenance of healthy brain function and repair, would contribute to the understanding of the biology of Alzheimers disease.

The Phase I trial will specifically test ImmunoBrain Checkpoints proprietary antibody, IBC-Ab002, which is targeted to enhance the immune system and induce brain repair processes in individuals with Alzheimers disease. Earlier this month, the company won a $1 million grant from the Alzheimers Association to help get them closer to the trial.

The brain is isolated from the blood by barriers that are collectively called the blood brain barrier, Schwartz explained. Although the brain is the highest tissue in terms of consumption of oxygen and it is dependent on robust blood supply, there is no direct contact between the blood vessels and the brains tissue. Accordingly, the brain has long been considered to be isolated from the immune system.

Blood Sugar And The Brain

The brains damaged ability to use glucose in AD is so important that some researchers call AD Diabetes Type 3. This observation has led to treatments aimed at repairing a metabolic defect by enhancing the effect of insulin. Intranasal insulin continues in testing with some promising early results.

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Benefits Of Becoming Involved In Clinical Trials

• Participants get to take an active role in their plan of care
• Individuals involved in clinical trials contribute to helping others
• Many clinical trial participants receive free medical care by experts in their respective field of medicine
• Those involved in clinical research receive the latest in medical advances before they are available to the general public
• Participants may be able to continue treatment/medication even after the clinical trial is over
• Those with chronic untreatable illnesses gain hope for a brighter future or perhaps even a cure for the disease
• Clinical trials can provide a positive milieu in which participants can seek the support of others going through the same experiences regarding their disease

Section : Early Stage Clinical Drug Development

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What Kinds Of Research Can You Participate In

Research involving people is called clinical research. There are two types of clinical research studies: observational studies and clinical trials.

• Observational studies are designed to collect information from people and compare that data over time. This helps them learn how different behaviors or lifestyles relate to health and disease and to understand how a disease progresses over time.
• Clinical trials are a type of research that tests new drugs, medical devices, surgical procedures, or behavior and lifestyle changes, such as exercise. Clinical trials may also test ways to detect and diagnose diseases and to better care for those living with diseases. Researchers determine if what is being tested, called an intervention, is safe and effective by comparing results in the test group to those in the control group.

The Alzheimers.gov Clinical Trials Finder includes listings for both kinds of clinical research studies.

International Clinical Trials Websites

A searchable database of clinical trials in the United States provided the Alzheimer’s Disease Education and Referral Center*. Alzheimers disease clinical trials database

ClinicalTrials.gov provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions. Updated database of information about clinical research in the United States, as well as other countries including Australia. To look at current and past dementia related trials, type ‘dementia’ or ‘Alzheimer’s’ into the search bar.

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The Diagnosis Of Ad Should Be Supported By Biomarkers

An important learning is the relatively large number of individuals who have a prodromal AD or AD dementia phenotype but are not amyloid-bearing when studied with amyloid PET . These non-amyloid individuals have suspected non-Alzheimer pathology and are presumed not to have AD. They should be excluded from trials of agents for AD. Table 3 shows the percentage of patients meeting clinical criteria for prodromal AD or mild AD dementia who are amyloid-bearing . Amyloid is more common in those with ApoE genotypes but genetic characterization is insufficient to ensure the presence of amyloid. To be confident that the trial population has AD, amyloid imaging or CSF evidence of the AD A/tau signature should be collected .

Why Is Diversity Important In Clinical Trials

Researchers need participants who represent all types of races and ethnicities, genders, geographic locations, and sexual orientations.

When research involves a group of people who are similar, the findings may not apply to or benefit everyone. When clinical trials include diverse participants, the study results may have a much wider applicability.

Having diverse people in studies can help researchers understand how dementia affects certain groups, why some communities are disproportionately affected by certain dementias, and which treatments or prevention strategies may be most effective in particular groups.

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How Long Before Alzheimers Vaccines Become Available

While the research into Alzheimers vaccines is exciting, its important to keep emotions in check. The clinical trial process exists to keep people safe from harmful side effects, and it can take many years for a treatment to get through the approval pipeline.

With a handful of Alzheimers vaccines in phase 2 and 3 trials, an approval could be expected in the next 5 to 10 years. But thats only if the vaccines prove to be both safe and effective. Its likely that new potential vaccines will continue to enter the development pipeline in the foreseeable future.

Alzheimer sixth leading cause of death in the United States, which means that a safe and effective vaccine would get a lot of attention and might be eligible for a special approval process.

The FDA has many expedited approval processes, including Breakthrough Therapy and Accelerated Approval among others, which could help bring an Alzheimers vaccine to market more quickly.

Alzheimers disease currently has no cure, and more effective treatments are needed. One avenue that researchers are pursuing is Alzheimers vaccination.

A vaccine for Alzheimers disease could take many forms. It could focus on the:

• beta-amyloid plaque

What Are The Three Phases Of Clinical Trials

When a new drug, vaccine, or other intervention is being considered for wide use, it will usually go through clinical trials. Clinical trials are conducted in three stages, called phases.

These phases are generally done in order, with one phase concluding before the next phase begins. In between phases, experts will review the results to make sure it is safe to proceed to the next phase.

Before phase 1 begins, testing is usually done in laboratory models or in animal studies. But no matter how good the models are, they still need to be tested in humans.

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What Research Currently Exists Around Alzheimers Disease

Alzheimers is one of the most researched diseases in medical science. Todays most promising research areas focus on how Alzheimers affects the brain. By understanding the disease process, it may be possible to gain insight on how it first develops.

Recent research has shown Alzheimers creates chronic low-level inflammation in the cells of the brain. By acting directly on the mechanisms for this inflammation, it may be possible to halt disease progress, especially by allowing the immune system to activate against harmful proteins.

How To Talk With Patients About Dementia Clinical Research

When talking with patients about participating in clinical research, the following tips can help guide your discussion:

• Mention the possibility of a clinical trial after the patient and caregiver/family member understand the diagnosis of dementia and their care options. Try setting aside time at the end of the patients appointment to discuss clinical research.
• When possible, use a team-based approach for discussions: Patient navigators, support staff, caregivers, and family members should be invited to participate.
• Advocate for consideration of participation, rather than directly encouraging participation.
• Aim to facilitate a patients understanding of clinical research as well as how they might play a role in scientific discovery.
• Recognize concerns and respond to those clearly using easy-to-understand language. Patient-centered communication, such as open-ended questions and empathetic listening, may help.
• Be sensitive about the timing of the conversation and how much information you provide. Offer time for the patient and caregiver to process the information.
• Provide patients and family members with a printout or link to the Alzheimers.gov article: Volunteer for Research: Alzheimers and Related Dementias Clinical Trials.

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Cu Alzheimer’s And Cognition Center Clinical Trials

Pilot Phase 2 Trial of the Safety & Efficacy of GM-CSF in the Treatment of Alzheimer’s Disease

*This study is completed*

Purpose – to examine the safety and efficacy of the study drug, Sargramostim on memory in adults with Mild-to-Moderate Alzheimer’s Disease

See more at clinicaltrials.gov

A medicine that is FDA-approved for bone marrow stimulation will be tested for its ability to be tolerated by Alzheimer’s disease patients and potentially to improve their memory.

To learn more about the research that led to the Leukine clinical trial, please click on these links:

• GM-CSF upregulated in rheumatoid arthritis reverses cognitive impairment and amyloidosis in Alzheimer mice PubMed
• Granulocyte Macrophage Colony Stimulating Factor Treatment is Assoliated with Improved Cognition in Cancer Patients PubMed

For more information about this study, please contact the study coordinator:

Michelle Stocker, BA

Phone: -724-7421

A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia

A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.

Clinicaltrials.gov Identifier: NCT04374136

To learn more about this study, visit clinicaltrials.gov

For more information about this study, please visit clinicaltrials.gov

Clinicaltrials.gov identifier: NCT04241068

*This study is no longer enrolling*

The Devastation Of Alzheimers Disease

With all this said, we are extremely aware of the gradual and cumulative devastation that Alzheimers disease causes, as patients lose their memory and cognitive functioning over time. In late-stage disease, people can no longer hold a conversation or respond to their environment. On average, a person with Alzheimers disease lives four to eight years after diagnosis, but some patients can live up to 20 years with the disease.

The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimers disease and this number is expected to grow as the population ages. Alzheimer’s is the sixth leading cause of death in the United States.

Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients. As a result of FDAs approval of Aduhelm, patients with Alzheimers disease have an important and critical new treatment to help combat this disease.

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Clinical Trials For Alzheimers Disease: Whats New

James M. Ellison, MD, MPH

Swank Center for Memory Care and Geriatric Consultation, ChristianaCare

Not since 2003 has a new medication been approved by the FDA for treatment of Alzheimers disease . Fortunately, this long dry spell may be nearing an end. This article explores a variety of clinical trials that may one day provide new treatments and methods to more effectively manage Alzheimers disease.

Who Can Participate

Nearly everyone! When people think of clinical research for Alzheimers and related dementias, they may think that only people with dementia can participate. But thats not true! To produce meaningful results, Alzheimers and related dementias researchers need a variety of volunteers, including:

• People who are healthy, without symptoms of dementia
• Both younger and older people
• People diagnosed with Alzheimers or a related dementia, such as Lewy body dementia, vascular dementia, or frontotemporal dementia
• People who are identified as at-risk, given their family history, genetic makeup, or biomarkers, which are measures that could signal very early stages of disease
• People with Down syndrome, who are at higher risk for Alzheimers disease
• Caregivers of people with dementia
• People from diverse and underrepresented groups, such as those who are Asian, Black/African American, Hispanic/Latino, Native American, and/or Pacific Islander

Each study has specific requirements for participants, called inclusion and exclusion criteria. Check the qualifications to see if you may be eligible to participate.

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