New U.K. Trials Network to Accelerate Dementia Studies

On January 24, the U.K.’s National Institute for Health and Care Research (NIHR) announced £49.9 million in funding to expand its Dementia Translational Research Collaboration (D-TRC) by creating a trials network led by Catherine Mummery of University College London (press release). This is the largest government grant for dementia research in the U.K. The D-TRC-TN will, in part, expand access to clinical studies to people who do not live near dementia centers, providing patients support, as needed. It aims to increase recruitment, especially of people with diverse backgrounds, streamline the setup and protocols of Phase 1 and 2 trials, and foster industry support for the same. Trials will focus on treating all dementias, including Alzheimer’s disease, frontotemporal dementia, and dementia with Lewy bodies. Mummery told Alzforum the trials could be for any stage of disease, though will typically recruit people in mild stages.

“Currently in the U.K., we don’t have enough sites that can do highly intensive Phase 1 studies,” Mummery told Alzforum. “There are a lot of sites that are keen to get involved but just don’t have the expertise, even if they have the facilities. The trials network aims to embed training frameworks from sites with expertise into those without.”

Mummery runs innovative trials involving invasive and sometimes risky therapies, such as BIIB080, an antisense oligonucleotide (ASO) targeting tau, and an siRNA against amyloid precursor protein mRNA. These are usually administered intrathecally, requiring specific expertise (Apr 2023 news; Nov 2023 conference). As with most genetic therapies, trials are small, involving tens of subjects, and require highly trained staff, specialty equipment, and close patient supervision. However, some think the drugs have tremendous potential. The D-TRC-TN will establish a trial network with the expertise needed to run such rigorous studies.

Expanding Access. The dementia trial network will support sites in 17 cities, almost doubling its capacity. It will focus on five sites (green) from this year, and the remainder from 2025 (red). It aims to support at least three more sites over the next five years. [Courtesy of Catherine Mummery, University College London.]

UCL, which will host and coordinate the D-TRC-TN, aims to establish at least 20 clinical sites across the U.K. in two stages (image at right). This year, Mummery and colleagues will focus on five sites, implementing changes to accelerate trial setup and improve recruitment, trial quality, and the number of trials each site can run. If those changes work, they will be adopted at other sites starting next year. A new, centralized database will standardize and keep track of staffing capacity and site availability, which is currently recorded piecemeal at different sites.

Fellowships will help staff complete the training and gain the expertise they need to run trials. Mummery envisions a new, streamlined career path to ensure the network will have the staff it needs to ramp up trials.

The grant also provides funds for regular meetings with companies interested in conducting trials in the U.K. “We want to provide a forum where industry and key opinion leaders can discuss trial protocols, regulatory procedures, and other aspects of clinical trial work,” Mummery said.

Money is also slated for high-tech biomarker measurements and outcome markers that can enhance trial protocols. For example, Mummery and colleagues will add stable isotope labeling kinetics (SILK) analysis in a Phase 1b trial of the tau ASO NIO752,  to track tau production and clearance in real time (Mar 2018 news). This type of trial is covered by the D-TRC-TN grant.

Which therapies might be tested in this new network? Mummery said they will focus on disease-modifying pharmacological treatments, including immunotherapies, genetic therapies, and vaccines, depending on which biopharma companies collaborate. She welcomes all inquiries.—Chelsea Weidman Burke

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References

Therapeutics Citations

  1. BIIB080
  2. ALN-APP
  3. NIO752

News Citations

  1. Paper Alert: Tau Antisense Oligonucleotide BIIB080 Hits Its Target
  2. Isotope Labeling Links Tau Production to Aβ Burden

Other Citations

  1. Nov 2023 conference

External Citations

  1. press release

Further Reading

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