Premium
Precision Functional Assessment for Alzheimer’s disease (PFA‐AD): A pilot study framework
Author(s) -
Lopez Claudia M.,
Hernandez Gerson D.,
Wang Yiwei,
Wershiner Dana,
Gisler Trang,
SeyfertMargolis Vicki,
Brinton Roberta Diaz
Publication year - 2020
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1002/alz.046289
Subject(s) - clinical trial , activities of daily living , medicine , disease , cognition , physical medicine and rehabilitation , psychology , physical therapy , psychiatry , pathology
Background Current clinical trial assessments of cognitive function and activities of daily living are based on periodic assessments conducted under controlled clinical conditions using standardized measures. This approach is highly correlated with diagnosis of Alzheimer’s disease (AD) but has varied relevance to the real‐life challenges of those living with the disease and their caregivers. The use of digital technologies in clinical trials is actively encouraged. The opportunity to embed these tools in clinical trials in parallel with traditional measures is needed to move the field forward. This pilot study provides a framework to build on this approach and expand its use in research and patient care management. PFA‐AD will enable: 1) identification of key behavioral challenges that are relevant to the person with AD and their caregivers; 2) assessment of therapeutic effect in real time across multiple domains of behavioral function; and 3) innovate clinical trial measures of daily activities that are personalized and relevant to the patient and caregiver. Method PFA‐AD proof‐of‐concept development was embedded as part of a clinical trial (Clinicaltrials.gov: NCT03748303) to further develop allopregnanolone, a first‐in‐class regenerative therapeutic for AD. This study is enrolling 12 persons with AD to assess the intramuscular formulation of allopregnanolone. Participants are being asked to download the “Allo IM app” and interact with it daily during 12‐weeks. The platform/app created by MyOwnMed,Inc supports simple digital measures of lifestyle and daily function defined by the team interacting with patients. Content is personalized for each patient/caregiver based on their input. Wearable technologies have been integrated to capture physical activity and sleep, using available interfaces that will be seamlessly integrate into the app. Result Analysis of PFA‐AD data will include: 1) App usability; 2) Fidelity of personalized measures; 3) Correlation of personalized measures with standardized assessments; 4) Feasibility for inclusion in clinical trials. Conclusion AD is personal and assessment of functional capacity can be too. The PFA‐AD application brings the power of precision analytics to those living with AD and their caregivers. Outcomes of this research will advance the development of a technology‐based tool to enable assessments of real‐life function that really matters, in real‐time.