• Aducanumab 07 September 2016 | View comments

  • ‘Tantilising signs that new Alzheimer’s drug could benefit early stage patients’ says Ian Semple in the Guardian August 31st. Thank goodness for the pointers the Guardian provides, there are so many initiatives to follow and the daily paper offers an easy and reliable filter.

    There had been some inkling of this in conversations with colleagues in recent weeks – the costing of treatment and services for people with dementia have been fairly well mapped out – but there was/is the prospect of something new, different and potentially very expensive on the horizon.

    Well here it is. The paper published in Nature – perhaps the most prestigious of journals – 1st September 2016 (537) 50-56, has 28 authors from institutions in the USA and Switzerland. It describes a study which involved 165 people with a diagnosis of ‘prodromal or mild Alzheimer’s disease with brain A_beta pathology confirmed by molecular PET imaging. They were treated with monthly infusions containing Aducanumab which is a human monoclonal antibody that has been shown to cross the blood-brain barrier. In mice it had been shown to clear away A_beta aggregates (amyloid).

    The trial in these 165 people was designed initially to explore ‘safety, tolerability, pharmacokinetics and pharmacodynamics’ but the results reported here go further than this.

    PET images show impressive clearance of amyloid plaques after one year – the clearance being most emphatic with dosage of 10mgm kgm-1 but evident at 3mgm-1 and 6mgm-1

    Adverse effects appear to be minimal in comparison with placebo.

    But the greatest interest focusses on clinical measures of cognition: MMSE showing falls of 2.81 points for the placebo cohort (32) within the year – people receiving active infusions of Aducanumab had falls which were significantly less at p <0.05

    CDR-SB showed similarly less deterioration of cognition for those receiving active treatment through the year.

    This is all amazing. The amyloid hypothesis has been with us for many years and massive investments have been made world-wide seeking therapies based on this. My understanding has been that other projects have shown it is possible to clear away amyloid but this has not been associated with improved outcomes of cognition. It has seemed that all that investment had been misdirected. Here is a careful study from respected sources which breathes new life into the hypothesis and gives new hope for people who develop Alzheimer’s disease.

    The implications for modes of clinical investigation and treatment costs and ethics are hard to cope with.

    For people living with dementia now and for their families, this paper will arouse agonies of wondering that they were born too soon.

    For people anxious that their memory , or the memory and behaviour of a loved one, is deteriorating it will raise concerns even further and is likely to escalate demands for additional investigations, earlier and costlier. Findings from such investigations will not proceed to treatment beyond those already licensed because this one-off small study, reported beyond its original design ambitions, is at odds with previous investigations based on the same hypothesis and the findings need to be replicated in much bigger studies.

    Something else for us to think about.

    Today I am reading about nanoparticles in the brain – air pollution and its consequences.

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