DDT COA #000004: PerfO to assess instrumental activities of daily living (IADLs)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology (DN I)
DDT COA Number
DDT COA #000004
Instrument Name
PerfO to assess instrumental activities of daily living (IADLs)
Disease/Condition
Alzheimer’s Disease
Concept of Interest
Day to day functioning
Context of Use
Adults (>45 years) with mild cognitive impairment due to Alzheimer’s Disease
COA Type
PerfO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium, Cognition Working Group
Contact(s)
Sonya Eremenco
Date Accepted into CDER’s COA Qualification Program
March 18, 2015
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
-- |
-- |
9/5/19 |