Clinical Research Informer

Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

Rethinking Clinical Trials

JANUARY 19, 2023

But this might obscure heterogeneity within groups, intersecting sources of vulnerability, and other vulnerable participants, such as people with dementia. The issue of informed consent comes up often with vulnerable populations that have dementia. – What if a patient has capacity to consent but their surrogate disagrees?

Trials

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Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

APRIL 18, 2024

Roche says one in nine Americans over 65 have Alzheimer’s dementia, the most common form of dementia. The incidence of dementia is growing worldwide, with 75 percent of cases remaining undiagnosed. million people live with Alzheimer’s disease in the US with the number of cases expected to rise to 13 million by 2050.

Clinical Trials

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Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication about Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS)

Rethinking Clinical Trials

DECEMBER 12, 2023

It utilized a waiver of consent; all eligible patients were randomized, and randomization was stratified by hospital and history of dementia at 3 hospitals in University of Washington system. Jumpstart is a pragmatic randomized trial of Jumpstart compared to usual care. It is something we are thinking about a lot in the outpatient trial.

Trials

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Biogen’s Aduhelm rollout goes from bad to worse

pharmaphorum

OCTOBER 21, 2021

. “Every day that passes we estimate that over a thousand Americans move from mild to moderate Alzheimer’s dementia, and therefore may no longer be appropriate for initiation of treatment with Aduhelm,” he said on a conference call.

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

JUNE 8, 2021

It also takes issue with the decision to approve the drug for all Alzheimer’s patients, rather than just the patients with mild cognitive impairment (MCI) and mild dementia included in Biogen’s studies of the drug. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.

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FDA Trims Broad Label for Biogen’s Alzheimer’s Drug Amidst Harsh Criticism

XTalks

JULY 12, 2021

The updated prescribing information states that the drug should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. On the other hand, Biogen is being aggressively questioned over its tacking on of such a hefty price tag for the drug.

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Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

XTalks

JUNE 9, 2021

It is administered monthly as an intravenous infusion to treat early Alzheimer’s disease and was developed for patients with mild cognitive impairment, not severe dementia. Aducanumab Controversy and Price Tag. Evidence for aducanumab’s efficacy has been highly contested. Biogen’s third trial was the Phase Ib dose-ranging PRIME study.

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AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials

XTalks

AUGUST 23, 2021

Mild cognitive impairment and dementia diagnoses should be disclosed to patients currently enrolled in trials as these are patients who would be eligible for treatment with aducanumab. With a $56,000 price tag for a year’s worth of treatment, Aduhelm is far from the most expensive drug on the market.

Clinical Trials

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Viagra ‘should be tested as Alzheimer’s therapy’

pharmaphorum

DECEMBER 7, 2021

The researchers from the Cleveland Clinic discovered the association between Viagra and a lower risk of Alzheimer’s as part of a wide-ranging study that looked at more than 1,600 FDA-approved medicines to try to find drugs that could be re-purposed as dementia therapies.

Drugs

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Women in Science Who Have Paved the Way Forward in Genetics

XTalks

FEBRUARY 11, 2021

She moved back to Ohio to live with family, and in her later years, developed dementia that led to short-term memory loss. They conducted two experiments, one with radioactive phosphorous to label DNA, and one with radioactive sulfur to tag protein (DNA does not contain sulfur and protein does not contain phosphate groups).

Genetics

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Clinical Research Informer

Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

Trending Sources

Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication about Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS)

Biogen’s Aduhelm rollout goes from bad to worse

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

FDA Trims Broad Label for Biogen’s Alzheimer’s Drug Amidst Harsh Criticism

Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials

Viagra ‘should be tested as Alzheimer’s therapy’

Women in Science Who Have Paved the Way Forward in Genetics

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