Almost 7 million people are living with Alzheimer’s disease (AD) in the United States alone.1 This number is expected to increase by 100% by 2060,1 putting even more pressure on researchers to quickly deliver meaningful breakthroughs on effective therapies.
But, from highly specific inclusion criteria to advanced imaging and biomarker assessments, Alzheimer’s clinical trials are uniquely complex. They demand specialized support from an Alzheimer’s contract research organization (CRO) with deep central nervous system (CNS) expertise, end-to-end operational support, and a flexible, collaborative approach. Here’s why.
Expertise Matters More in Alzheimer’s Research
AD trials are some of the most difficult and delicate in CNS research. Unlike more straightforward indications, they require a nuanced understanding of:
- The progressive nature of cognitive decline
- Always-evolving biomarkers
- Amyloid-related imaging abnormalities (ARIA) detection and management
- And more
Alzheimer’s research recruitment is also incredibly difficult. Thanks to strict eligibility and biomarker requirements, AD trials can have screen fail rates as high as 88% — more than double the industry average of 36.3%.2,3 AD trials also face patient retention issues, especially in long Phase III studies, with some multi-year trials losing up to 54% of patients before study close.4
With 98% of Alzheimer’s drugs failing in clinical trials since 2003,5 it’s critical to partner with an experienced Alzheimer’s CRO with the clinical, scientific, and operational depth to anticipate obstacles and confidently navigate them.
End-to-End Services: A Nonnegotiable for AD Trials
When it comes to AD, study execution is only the beginning. Alzheimer’s trials usually involve multiple endpoints and complex procedures like MRI and PET imaging and cerebral spinal fluid (CSF) collection, as well as varied biomarker analysis and complex regulatory documentation. With so many moving parts, even a minor misstep can delay timelines or compromise data integrity.
Outsourcing to fragmented providers adds even more complication, often leading to data inconsistencies, communication breakdowns, and more risk.
The fewer handoffs, the fewer surprises. An Alzheimer’s CRO partner that offers seamless, end-to-end services can help deliver faster timelines and better data.
Flexibility Wins in Alzheimer’s Trials
AD protocols are known to evolve mid-study in response to new data or regulatory input — making adaptability a must. And, with screen failure rates as high as 88%,2 sites need personalized support and realistic feasibility plans, not one-size-fits-all setups.
Alzheimer’s studies with strong cross-functional communication and creative solutions are more likely to stay on schedule and deliver cleaner data, and an Alzheimer’s CRO that feels like an extension of your team will keep the entire study moving faster, smoother, and smarter.
Get Expertise, End-to-End Support, and a Tailored Approach With Clinilabs
As a full-service CRO focused exclusively on CNS drug development, we are uniquely qualified to support Alzheimer’s studies.
Case Study
Our position as the Alzheimer’s CRO of choice is exemplified by our work on a first-in-human Phase I AD trial investigating an IV-administered monoclonal antibody targeting amyloid in patients with mild AD or mild cognitive impairment (MCI). A placebo-controlled, single and multiple ascending dose trial, it involved seven patient cohorts at 17 different sites.
Here’s how our expertise, end-to-end services, and tailored approach led the trial to success.
Expertise & Experience
With over 800 CNS trials under our belts, we knew this Alzheimer’s study would demand more than standard protocols. Our team brought extensive knowledge of and deep experience with first-in-human biomarker strategies, ARIA, and AD patient safety to help shape every step and ensure the data we captured were meaningful and reliable.
End-to-End Services
We didn’t just manage the trial; we owned it from start to finish. Our solutions included:
- Identifying and qualifying 17 top-performing AD and MCI sites
- Delivering insights that informed 8 critical protocol amendments, including CSF sampling and end-of-study data collection
- Collaborating with vendors to ensure accuracy, quality, and timeliness
- Running a centralized data capture system that ensured clean, actionable data from day one
Customization & Collaboration
This wasn’t a set-it-and-forget-it study. We connected with the sponsor team every day to align priorities and maintain momentum. Our tailored feasibility strategy helped reduce site burden and accelerate enrollment, and our centralized EDC platform supported real-time monitoring and collaboration.
Even as the protocol evolved, we stayed agile — navigating 8 amendments without derailing the timeline.
The Results
The study saw impressive results:
- First patient enrolled in just 9 days
- 60 patients completed the study out of 260 screened and 65 randomized
- Study completed within 18 months, with closeout just 2 weeks after the last patient visit — 9 days ahead of schedule
Most importantly, the findings moved a promising Alzheimer’s therapy one step closer to the patients who need it.
Partner With a Proven Alzheimer’s CRO
Alzheimer’s trials demand more: more expertise, more precision, and more flexibility. At Clinilabs, we bring all three to every study we touch.
With an exclusive CNS focus, a track record of delivering complex trials ahead of schedule, and a collaborative approach that adapts in real time, we’re the partner sponsors rely on for critical Alzheimer’s research.
Ready to move your Alzheimer’s therapy forward?
References
1 Alzheimer’s Association. “2024 Alzheimer’s disease facts and figures.” Alzheimer’s & Dementia, April 2024. https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13809
2 Goldman, D., et al. Key Barriers for Clinical Trials for Alzheimer’s Disease. USC Schaeffer Institute. https://schaeffer.usc.edu/research/key-barriers-for-clinical-trials-for-alzheimers-disease/. August 202.
3 Getz, K. “Can Recruitment and Retention Get Any Worse?” Applied Clinical Trials. December 2019. https://www.appliedclinicaltrialsonline.com/view/can-recruitment-and-retention-get-any-worse
4 Gabel, M., Bollinger, R., Coble, D., et al. “Retaining Participants in Longitudinal Studies of Alzheimer’s Disease.” J Alzheimers Dis. January 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC9673904/#
5 Kim, C.K., Lee, Y.R., Ong, L., et al. “Alzheimer’s Disease: Key Insights from Two Decades of Clinical Trial Failures.” Journal of Alzheimer’s Disease, May 2022. https://content.iospress.com/articles/journal-of-alzheimers-disease/jad215699