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Special report: With millions people living with Alzheimer’s around the world, you’d think it would be simple to find 174 patients to trial a promising new treatment.

But as Alzheimer’s fighter Actinogen announces it has secured 75 per cent of the patients needed for the trial of its lead drug Xanamem, the company also admits finding the right patients can be a challenge – regardless of a treatment’s potential.

Actinogen has deployed a number of tactics to inform, screen and enrol potential candidates for its clinical trial XanADu, a randomised, double-blind, multi-centre clinical study comparing Xanamem to placebo in subjects with mild dementia due to Alzheimer’s disease.

Last month, it announced the addition of five new study sites in the US and a partnership with dementia app developer, MindMate, to identify potential eligible patients.

More than 130 patients out of a total 174 have now been enrolled and begun the 12-week trial.

Actinogen head Bill Ketelbey says while there is a large pool of potential Alzheimer’s patients, XanADu trial participants must meet a number of strict requirements to ensure high-quality results.

“Patients must have mild dementia due to probable Alzheimer’s disease, be on stable medication for at least three months or treatment naïve and have a Mini Mental State Exam (MMSE) score of 20-26.”

The MMSE is a set of 30 questions commonly used by doctors and other healthcare professionals to check for cognitive impairment.

CEO Dr Bill Ketelbey is a veteran of the pharmaceutical sector, having helped to launch famous drugs such as Viagra and Aricept during his time at Pfizer. Pic: Actinogen
CEO Dr Bill Ketelbey is a veteran of the pharmaceutical sector, having helped to launch famous drugs such as Viagra and Aricept during his time at Pfizer. Pic: Actinogen

Patients must also be 50 years or older and have a spouse or friend who can provide information to the study doctor and attend the study site visits with the patient.

Ketelbey says while costs associated with finding these types of patients is a challenge for top studies, high quality patients are critical for high quality data.

The alternative for pharmaceutical companies, he says, is to target high density populations, often in developing countries.

“There are advantages, such as economies of scale, to target high density populations but it is important  to reach the right communities.”

“We selected the best study sites in three very competitive, highly-experienced and well-regulated countries: the USA, UK and Australia.”

“We also have study sites beyond the big cities as companies that fish in the same pool may risk running out of high quality patients.”

Ketelbey says Actinogen is also fortunate in that its treatment is a daily oral capsule, which makes XanADu an appealing study for patients and doctors.

“We  keep in continuous communication with our study sites and have developed several creative strategies to support their efforts to recruit and retain high quality patients, including an attractive publication policy once the study is complete.”

Actinogen expects to complete enrolment for XanADu later this year. Top-line results are expected in second quarter of 2019.

 

This special report is brought to you by Actinogen.

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