35 Therapies in Phase 2 and 3 Clinical Trials Raise Hopes in Alzheimer’s Community

Ana de Barros, PhD avatar

by Ana de Barros, PhD |

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Alzheimer's trials spurt

Alzheimer’s research is gaining momentum, with 27 Phase 3 and eight Phase 2 clinical trials either in progress or expected over the next five years.

The good news surfaced in a revised pipeline analysis of Alzheimer’s therapies that researchers presented at the Alzheimer’s Association International Conference in London. The event, which started July 16, runs through July 20.

Alzheimer’s patients, families, doctors and caregivers have been waiting a long time for some encouragement. It’s been 14 years since U.S. and European regulators approved a new treatment.

ResearchersAgainstAlzheimer’s made the presentation. The global coalition of Alzheimer’s researchers is pushing for more research money and policy reform to develop effective treatments for the disease by 2025. The group is one of the organizations in the UsAgainstAlzheimer’s network.

“The Alzheimer’s disease pipeline, marred by decades of failures and underinvestment, is due for big victories,” George Vradenburg, co-founder and chairman of UsAgainstAlzheimer’s, said in a press release. “Thanks to growing investment from industry leaders, we remain cautiously optimistic that the current crop of late-stage Alzheimer’s innovations will bring much-needed solutions to families in the near future.”

In addition to identifying therapies that are in, or are heading for, Phase 2 and 3 clinical trials, the revised pipeline analysis included milestones — dates when trials were expected to be completed, dates when companies were expected to file regulatory approval requests, and dates when treatments were expected to hit the market.

The analysis broke therapies into categories. It noted, for example, that 23 drugs in Phase 2 and 3 trials target amyloid protein buildup in the brain, while 28 drugs target neurotransmitter activity.

The last treatment that regulators approved for Alzheimer’s was Namenda (memantine HCl), an oral N-methyl-D-aspartate receptor antagonist. Forest Laboratories developed it to restore the function of damaged nerve cells and reduce overactive cell signaling. It works by inhibiting the receptor’s activity.

Namenda obtained U.S. Food and Drug Administration approval in 2003. The European Medicines Agency hasn’t approved an Alzheimer’s treatment since 2002.

ResearchersAgainstAlzheimer’s said signs of hope include an 18 percent increase in Phase 2 trials of treatments — from 49 to 58 — and a 7 percent increase in Phase 3 trials of therapies — from 30 to 32 — in the past year alone.

“There is no silver bullet when it comes to treating Alzheimer’s,” said David Morgan, a founding member of the organization. “The more we learn about the underlying Alzheimer’s pathology, the closer we get to a cure for a disease that is an enormous burden on patients, caregivers and global health systems.”

ResearchersAgainstAlzheimer’s said it will continue to track the progress of each treatment and monitor the processes by which the drugs are evaluated.

An important question that the analysis poses is whether Alzheimer’s patients can obtain access to the treatments once they’re developed. That, of course, is a question that centers on price.

“Private- and public-sector leaders will need to work closely with insurers in the coming years to ensure patients have access to these drugs when they are available,” Vradenburg said.