Concerns Raised by Senior Doctors Regarding Patient Consent for Alzheimer’s Drug Trials
- Doctors Express Fear of Dementia Patients’ Lack of Understanding of Drug Trial Risks
Concerns have been raised by senior doctors regarding Alzheimer’s patients’ potential lack of awareness when signing up for experimental drug trials.
Currently, there are approximately 190 dementia drug trials worldwide, including the UK, evaluating 140 different medications involving nearly 60,000 patients.
However, some of these drugs have been associated with serious side effects such as brain bleeds and strokes.
Doctors interviewed by The Mail on Sunday express their fear that many patients, due to cognitive impairment, may not fully comprehend the risks associated with participating in these trials.
Professor Robert Howard, an expert in Old Age Psychiatry at University College London Institute of Mental Health, states, “These new drugs are more potent than anything we’ve previously studied, raising the complexity of ensuring informed consent from patients.”
Senior doctors have warned that Alzheimer’s sufferers may be unaware of the risks of signing up for experimental drug trials (file photo)
There are currently just under 190 dementia drug trials assessing 140 different medications around the world, including the UK, involving nearly 60,000 patients (file photo)
Professor Aaron Kesselheim, an Alzheimer’s expert at Harvard Medical School, supports these concerns, stating that “This is a population that may not fully grasp the consent process” and emphasizing the need for investigators to ensure participants have a thorough understanding of their involvement.
A recent incident involved a US woman filing a complaint against a major pharmaceutical company after her mother suffered a stroke following the intake of an experimental Alzheimer’s drug. The woman, who wishes to remain anonymous, revealed that her 84-year-old mother had enrolled in the trial without her knowledge. It wasn’t until her mother’s confusion and subsequent hospitalization that she discovered the participation in the trial.
The woman expressed her concern about her mother’s ability to consent, given her significant memory impairment, stating, “How was it possible for her to consent to this study?”
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