Patients left in limbo as Alzheimer's trial awaits ethical approval

IAN and Pat Cleaver ''made a mutual contract nearly 60 years ago, and that's not meaning a legal contract'', Mr Cleaver said. ''It's a contract between ourselves to look after one another.''

Mrs Cleaver's Alzheimer's disease makes her dependent on her 85-year-old husband, who still manages the couple's sheep and wheat property near Nyngan. Sometimes she joins him on the truck. Other times she spends a day at an aged care facility.

''Pat's not at an unworkable stage but I guess the progression of it means she will be,'' said Mr Cleaver, who hopes some of his wife's failing abilities will return if she can join a Queensland clinical trial of a radical new therapy.

But despite accepting more than $100,000 in donations from families of dementia patients, and signing up hundreds of potential participants such as 81-year-old Mrs Cleaver, Griffith University does not have the necessary research ethics approval to go ahead with the study, which will be limited to only 12 patients.

The proposal, to test a controversial drug injection technique that some relatives say produces stunning recovery, was condemned this week as cruel and unethical for raising unrealistic hopes and linking fund-raising to the possibility of participation.

A professor of medical education at the University of Sydney, Merrilyn Walton, said Griffith was ''overstating the results in a positive frame … to generate money from a particularly vulnerable group who are very interested in research, very invested in a cure.''

A professor of ageing and mental health at the University of NSW's dementia collaborative research centre, Henry Brodaty, said the study, which will not compare the drug to a placebo, would ''achieve very little. It's not going to give any definitive answers.''

Professor Brodaty said the treatment - which involves injecting the powerful immune system drug etanercept between the bones of the neck, then tilting the patient to trap it in brain fluid - was being promoted without sufficient scientific backing.

''I hope it works but until we've got more evidence … it worries me,'' he said. ''People get so excited and pin so much hope on this … I think it's cruel.''

The director of the Griffith institute of health and medical research, Lyn Griffiths, acknowledged the trial's future was uncertain. Three doctors would travel to California next week to receive training from the private clinic that pioneered the injections.

''We don't know whether they will complete the training or whether [the university's human research ethics committee] will be happy with it,'' she said.

The university would also need to find a hospital prepared to perform the procedure.

Professor Griffiths said the university had raised more than the $100,000 required for training, administration and drug supplies, and would not accept further money. After the Herald submitted questions, the university removed the donations button from the trial website.

Professor Griffiths defended the promotion of the trial. ''There's a real need for treatments,'' she said. ''I don't think there was any sense people were hoodwinked.''

Mr Cleaver is frustrated by the delay. ''They said quite emphatically they were ready to start,'' he said. ''We have this drug available and it doesn't seem logical not to use it.''

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