https://www.linkedin.com/pulse/50mforalz-my-wish-list-ad-research-ronald-louie/
My wish list for AD Clinical Trials (if I were to win the lottery):
1. Appoint and fund an accountable, identifiable Alzheimer Clinical Research Czar to coordinate and accomplish the concrete goals of this list. Emphasize human clinical research, since lab-based work gets other funding.
2. Simplify research consents for patients and caregivers.
3. Develop practical recruitment strategies for online enrollment, nursing homes, senior centers, places of worship and other sites; realize this is labor intensive and best done face to face.
4. Commission the development and vetting of practical instruments to detect improvements or problems within weeks rather than months (such as electronically monitored surrogates of cognition/function like work done at Harvard on iPads or at OHSU with wearables) and other creative ideas.
5. Focus on “repurposing” drugs already FDA approved, with rational promise, and commission empiric clinical trials (agents as mentioned by J. Cummings at Cleveland Clinic and others).
6. Develop a comprehensive strategy for categorically testing all agents, perhaps even re-testing agents those that failed Cochrane Review meta-analysis because of poor methodology, including OTC, nutritional (curcumin, coconut oil) and non-drug therapies.
7. Commission three or four agent combination clinical trials in severe patients (like Phase I-II chemo trials in the sickest patients).
8. Commission the development and publication of innovative cross-over trial designs (similar to “Pick the Winner” strategy used in adult leukemia trials) to use as templates. Create statistical group to consult and prevent “P-hacking.”
9. Accelerate the creation of a national IRB for AD work, like the NCI’s Centralized IRB’s for adult and pediatric cancer, or pay fees to national commercial IRBs who develop ethical expertise in AD clinical research.
10. Create an ethically driven template which facilitates power of attorney and other issues for caregivers.
11. Extend the AD-PCORI (Patient Centered Outcomes Research Institute) network and scope (extend work on behavioral observations and therapies, self or caregiver assessment tools)
12. Commission ethical clinical trials in other countries (China? EU? SA?)
I realize this is somewhat naive, and ignorant of the vast history of AD clinical work, so please grant me some forgiveness in advance! It’s from my perspective of 30 years in clinical pediatric cancer research, with some successful but some unsuccessful trials along the way.
[NIH image public domain: fMRI of jazz musician improvising]