When You Have A Disability Virtual Friendships Can Be Special
Wednesday, July 6, 2022, 11:26 AM
When we think about how COVID has changed the way we live our lives, we think a lot about mask manda
When we think about how COVID has changed the way we live our lives, we think a lot about mask mandates, vaccines, and Zoom meetings. We think about in-person jobs switching to remote or hybrid. Unfortunately, a conversation about how it affects people with disabilities isnt too common.
It should be.
Ive heard from friends that theyre paying a lot more in ridesharing fares. Im thankful I havent noticed a spike, but that could very well be location-based.
Many of my friends are actually struggling with the job search. Yes, a lot of things have gone remote, but a lot of remote jobs are requiring the completion of assessments, and a lot of these end up being inaccessible. Friends who are looking out of state are struggling with residency requirements to qualify.
Another issue? The lack of social interaction. You may think the lack of social interaction isnt as big of an issue as it was two years ago, when COVID was at its peak, but Ive noticed it myself lately and have talked with friends who feel it, too.
And these friends Im talking about? They arent just the ones that Im lucky enough to know personally. I also have some good friends Ive actually never met in person.
I met another through interacting on another persons Facebook page, so she added me , and now we have regular movie nights together over FaceTime.
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Dr Maria Carrillo Chief Science Officer Medical And Scientific Relations Alzheimer’s Assn National Office Chicago Illinois Receives The Alumnae Of Northwestern’s 2018 Alumnae Award
Dr. Maria Carrillo, Chief Science Officer, Medical and Scientific Relations, Alzheimers Association National Office, Chicago, Illinois, is the recipient of The Alumnae of Northwestern Universitys 2018 Alumnae Award.
The Alumnae Award recognizes a woman who has brought honor to Northwestern University through outstanding professional contributions in her field and who has attained national recognition. Established in 1976, the Alumnae Award has been presented every year to an alumna who has had a significant impact in her field of endeavor. Educators, journalists, doctors, and artists are included among The Alumnaes roster of award recipients.
Dr. Carrillo holds a bachelors degree in psychology, with a minor in biology, from the University of Illinois, and a doctorate in neuroscience from the Neuroscience Institute, Cell, Molecular and Structural Biology department, Northwestern University.
Dr. Carrillo was named Chief Science Officer in 2015. Prior to that she was vice president, senior director and director, Medical & Scientific Relations, at the Alzheimers Association National Office. She served as an assistant professor at Rush University Medical Centers Department of Neurological Sciences and instructor and post-doctoral fellow at Rush-Presbyterian-St. Lukes Medical Centers Department of Neurological Sciences.
News Release, EVANSTON, Ill.
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Important Remaining Questions And Considerations
Although the current consensus panel recommendations address many critical questions inherent in determining the overall quality of clinical trials in aging and dementia, there remain many other important questions that should be recognized, prompt further discussion, and serve as a focus for future efforts to guide high-quality studies in the field. Given the extensive knowledge accumulated through clinical trials and observational studies, there is much debate on the need to include placebo control groups in future Phase II and III studies. Although the exclusion of placebo controls in Phase I studies is common, it is unclear if current study simulation methods could replace control groups in future studies. Given the variability in disease characteristics and progression across randomized, controlled trials and observational cohorts, it is clear that there remains much work to do in this area of clinical trial design. Additionally, current Food and Drug Administration, European Medicines Agency, and other regulatory guidances maintain requirements for contemporaneous control groups for adjudicating safety and treatment effects in the changing landscape of degenerative disease clinical trials. For now, placebo control groups remain essential for safety and efficacy evaluation.
Rough Start In Trying For More Time
Aducanumabs path toward FDA review, and possible approval, has been rather unique and quite tumultuous.
After early trial data indicated that aducanumab had an acceptable safety profile and could reduce levels of amyloid plaques, the abnormal protein clumps that are a hallmark of Alzheimers, in patients brains, Biogen working with Eisai launched two Phase 3 trials. Those studies, ENGAGE and EMERGE , aimed to evaluate the investigational therapys efficacy over 78 weeks of monthly intravenous infusion treatments.
Each trials main goal was to determine the effect of treatment on the rate of change in Clinical Dementia Rating-Sum of Boxes , a composite measure of functional and cognitive abilities that assesses skills like engaging in home activities, solving problems, and being active in a community. Collectively, the studies enrolled nearly 3,300 people with either mild cognitive impairment due to Alzheimers, or mild Alzheimers.
A planned independent advisory committee assessment of interim data from these Phase 3 trials, however, determined that aducanumab was unlikely to benefit patients, and Biogen announced in 2019 a halt to its clinical development.
Based on these data, Biogen announced it was reversing course, and would request approval in the U.S., as well as in Europe and Japan.
Those later findings, Carillo said, are crucial to the Alzheimers community, because no current treatment offers any such hope.
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Adherence To Regulatory Principles And Standards
Irrespective of the âqualityâ of a clinical trial, all should adhere to common GCP/HSP regulations that require an overseeing regulatory body, which at minimum requires an appropriate IRB/REC and approved consent process. The consent document should include contact information for that regulatory body as well as a contact if participants have questions, concerns, or complaints. In addition, âhigh-qualityâ studies that intend to appropriately share and or publish their results, should be registered as such with appropriate agencies such as through ClinicalTrials.gov. Unregistered trials involving the proposed use of unapproved or experimental medicines or interventions should signal that the trial may not actually be a trial at all, or that it may be of lower quality. Intent to publish or share such results in reputable medical and scientific journals require such registration, and a failure to do so indicates a lower quality study that may be seeking to avoid such requirements. In addition, financial interests including personal or family gain, institutional gain, or other financial conflicts should be appropriately disclosed to participants. Studies involving excessive or unexplained financial gains should indicate a âlower-qualityâ study.
Four Protections Under The Fair Housing Act And Americans With Disabilities Act You May Not Know
Monday, July 18, 2022, 10:31 AM
The Americans with Disabilities Acts 32nd Anniversary is on July 26th! This landmark legislat
The Americans with Disabilities Acts 32nd Anniversary is on July 26th! This landmark legislation has been instrumental in advancing civil rights for people with disabilities. While we celebrate the ADAs impact in the lives of one in four Americans living with a disability today, Easterseals, along with disability advocates across the country, are actively fighting to ensure that protections under this legislation are honored and enforced.
Throughout the decades since the ADA was signed into law, advocates have also worked to eliminate gaps and loopholes when it comes to ADA protections that are often overlooked. That work continues to this day. People with disabilities still experience barriers in all areas of life, including employment, financial stability, education, and heath care. Securing accessible housing isnt without its challenges, too, and in a housing industry that is often difficult to navigate, many may not be aware of the protections they do have.
If youre thinking about renting or buying, now or in the future, make sure you remember these four protections from Freddie Mac and Alabamas Center for Fair Housing:
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Even With The Ada Disability Employment Has A Long Way To Go
Wednesday, July 20, 2022, 2:52 PM
We are happy to introduce a guest blogger today Grace W. Dow. Grace is an advocate and a wri
We are happy to introduce a guest blogger today Grace W. Dow. Grace is an advocate and a writer. Through her writing, Grace places a spotlight on various disability issues and perspectives as a person with cerebral palsy.
The 32nd anniversary of The Americans with Disabilities Act takes place on the 26th of this month. While this was a defining moment for the community, equality for disabled people in the United States still has a long way to go. Physical access to restaurants, stores, and schools is excellent. Because of the ADA, I attended local public schools when I was growing up. This meant that I could go to sporting events and other activities at school as well. I could watch my younger siblings sporting events because the gym was ADA compliant. However, physical accessibility is only one aspect of equality. Ableism and related attitudes hold us back more than you may think.
Ive been looking for work for the past three years and have been unsuccessful. Too often, when employers find out that I have Cerebral Palsy, they are no longer interested in hiring me. Such discrimination is illegal according to the ADA, yet it still happens. Employers need to embrace having those with disabilities as a part of their workplaces. Ableism is the real reason why I am unemployed right now.
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Impossible To Wait Five More Years
While the EMERGE trial met its primary goal, ENGAGE did not in the overall trial, no significant difference in the rate of decline in CDR-SB was seen between those given aducanumab or a placebo.
Based in large part on these ambiguous results, an FDA advisory committee decided late last year that sufficient evidence is lacking to support the therapys effectiveness. The FDA considers, but is not bound to, recommendations by a committee. More recently, a recent interim report by the independent Institute for Clinical and Economic Review reached a similar conclusion.
Biogen, meanwhile, points out that treatment effect was seen in ENGAGE, though only in the relatively small subset of patients on its high dose. According to Carrillo, differences in dosing are key to understanding the outcomes of the two trials.
Probably a bit into the Biogen launch of EMERGE and ENGAGE, science emerged from a few trials that demonstrated that there was less bioavailability of these monoclonal antibodies than we originally thought, Carrillo said.
In other words, data indicated that, for aducanumab and medications like it, less of the active medication was getting into the brain than expected. Based on these findings, an increase in dose was not only recommended but actually safe, Carrillo added.
Even people who had symptomatic ARIA, dizziness, maybe some even confusion and cognitive issues, weve and then reintroduced later again safely, she said.
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