2024 American Academy of Neurology Abstract Website

Objective:

To compare age demographics of Alzheimer’s Disease (AD) trial subjects vs. Alzheimer’s Disease and related dementia (ADRD) patients using Real World Data (RWD).

Background:

The Food and Drug Administration recommends that clinical trial study populations reflect the patients likely to use the product, if approved. Age is an important demographic variable to consider in clinical research, especially with ADRD.

Design/Methods:

An electronic search of the ClinicalTrials.gov website identified “Alzheimer’s Disease” trials sponsored by “Industry”, involving AD patients only (i.e., non-AD patients and/or healthy subject trials were excluded), designated as Phase 2, 3 or 4 trials with a start date listed (accessed on October 3, 2023).

The TriNetX Analytics Network contains electronic health records from >150 million individuals from >70 Health Care Organizations across the United States. Database queries were performed for ICD-10 G30 (AD) and F03 (Unspecified dementia).

Results:

A dataset of 418 trials was assessed for the maximal subject age allowed per trial. Data were collated into 3 groups (i.e., age limits of <80, <85 or > 85), and then by Study Start Date. Pre-2010, 127 of 172 (78%) trials had an upper age limit >85 years. Only 3% of pre-2010 trials had age limits <80. From 2010-2019, 53% of AD trials had an age limit >85, while trial age limits <80 had increased to 11%. Since 2020, 39% of AD trials have had an age limit of <80.

The RWD from TiNetX confirms the age-related prevalence of AD patients. These RWD indicate that an upper age limit of <80 in a clinical trials excludes 55% of ADRD patients in the US, while an age limit of 85 years would exclude 33% of ADRD patients.

Conclusions:

Underrepresentation of older ADRD subjects in clinical trials has increased significantly in recent years, indicating that trial age limits should be considered carefully.