Senior doctors worry about patient consent to Alzheimer’s drug trials – as they may not be aware of the risks
- Doctors fear that patients with dementia cannot understand the risks of drug trials
Senior doctors have warned that people with Alzheimer’s disease may be unaware of the risks of participating in experimental drug trials.
There are currently just under 190 dementia drug trials evaluating 140 different drugs around the world, including the UK, involving nearly 60,000 patients.
But some of the drugs have been linked to dangerous side effects, such as brain hemorrhages and strokes.
Doctors who spoke to The Mail on Sunday say they fear many patients, because of their disturbed mental state, are unable to understand the risks of signing up for one of these studies.
“These new drugs are stronger than anything we’ve studied before and getting patients to fully agree to participate is complicated,” says Robert Howard, Professor of Geriatric Psychiatry at University College London Institute of Mental Health.
Senior doctors have warned that people with Alzheimer’s may be unaware of the risks of signing up for experimental drug trials (file photo)
There are currently just under 190 dementia drug trials evaluating 140 different drugs around the world, including the UK, involving nearly 60,000 patients (file photo)
“The consent forms that patients have to sign before participating in these studies are complicated, even for someone without Alzheimer’s.
“If patients are desperate to try a treatment, they may not properly absorb the safety warnings. It’s crucial that we recruit people with Alzheimer’s into clinical trials or we’ll never find out how to treat the disease, but we need to do more to make sure the risks are properly explained to them.’
US experts have also expressed concern about the recruitment process for Alzheimer’s drug trials.
“This is a population that may not fully understand the consent process,” says Professor Aaron Kesselheim, an Alzheimer’s expert at Harvard Medical School.
“Detectives have to be careful and make sure people know what they’re dealing with.”
Last week it was revealed that an American woman complained to a major pharmaceutical company when her mother suffered a stroke after taking a new experimental drug for Alzheimer’s disease.
The woman, who wished to remain anonymous, told the Los Angeles Times that her 84-year-old mother had signed up for the trial without her daughter’s knowledge.
The woman had no idea her mother had started taking the drug until she became confused and had to be taken to hospital, where doctors discovered she had suffered a stroke.
She told the newspaper that her mother’s memory was already so bad that she struggled to understand her electricity bill. She added, “How was it possible for her to consent to this study?”