Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD)
Funds one bundled run from first-in-human through phase 2a for a dementia drug that works on something other than amyloid or tau.
Early dementia drug development loses years to the gaps between trials — each phase written, reviewed and funded separately while the compound waits. The National Institutes of Health funds the whole early stretch as one project here.
The applicant bundles independent protocols: a phase 1 trial together with phase 1b and phase 2a trials. They stay separate protocols, but they are planned, funded …
Bundled phase 1, phase 1b and phase 2a clinical trials of pharmacological candidates — small molecules or biologics — engaging non-amyloid and non-tau mechanisms to address cognitive or neuropsychiatric symptoms across the spectrum of Alzheimer's disease and related dementias, with prespecified go/no-go safety and tolerability milestones gating the advance between phases.
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