Senior doctors concerned over patient consent for Alzheimer’s drug trials

Senior doctors have warned that Alzheimer’s sufferers may be unaware of the risks of signing up for experimental drug trials.

There are currently just under 190 dementia drug trials assessing 140 different medications around the world, including the UK, involving nearly 60,000 patients.

But a number of the drugs have be linked to dangerous side effects, such as brain bleeds and strokes.

Doctors speaking to The Mail on Sunday say they fear many patients, due to their impaired mental state, are unable to understand the risks of signing up for one of these trials.

‘These new drugs are stronger than anything we’ve previously studied and it’s complicated to ensure patients can fully consent to taking part,’ says Robert Howard, professor of Old Age Psychiatry at University College London Institute of Mental Health.

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)

‘The consent forms patients are given to sign before they take part in these trials are complicated even for someone without Alzheimer’s.

‘If patients are desperate to try a treatment, it’s possible they won’t properly take in the safety warnings. It’s crucial that we recruit people with Alzheimer’s for clinical trials, otherwise we won’t ever discover how to treat the disease, but we need to do more to ensure the risks are properly explained to them.’

US experts have also raised concerns over 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.

‘Investigators need to be careful and make sure people know what they are getting involved with.’

Last week it was revealed that a US woman had raised a complaint with a major pharmaceutical firm when her mother suffered a stroke after taking a new experimental Alzheimer’s drug.

The woman, who asked to remain anonymous, told the Los Angeles Times that her 84-year-old mother had signed up to the trial without her daughter’s knowledge.

The woman had no idea her mother had begun taking the drug until she became confused and had to be taken to hospital, where doctors found she had a stroke.

She told the newspaper that her mother’s memory was already so poor that she struggled to understand her electric bills. She added: ‘How was it possible for her to consent to this study?’