Cognition assessment scale, sleep and learning in Down syndrome

University of Arizona

Principal Investigators: 

  • Dr. Jamie Edgin, PhD
  • Dr. Stephen Cowan, PhD
  • Dr. C Clark, PhD

Resources for clinical studies

Developing and validating a cognitive battery that can be used across the lifespan of individuals with Down syndrome (Ds) is necessary for clinical trials and other types of research. The purpose is to build a framework to assess a range of memory types, including verbal and non-verbal abilities, processing speed, and high-ordered thinking. A pilot study has already been completed to validate this assessment in 56 participants ranging in age from 2-to-25. Drs. Edgin, Cowan, and Clark are developing an iPad-based cognitive battery for Down syndrome throughout the lifespan.

FDA approval requires that clinical trials provide suitable endpoints to measure the effectiveness of the therapeutic agent. Success is based on reaching these endpoints. In order to conduct accurate clinical trials in the Down syndrome population, there is a critical need for updated, consistent, and reliable outcome assessments to measure the unique cognitive profiles of individuals. Since learning and memory are huge components of cognitive function, tasks that specifically assess both are of utmost importance. The development of novel assessments for use in this way would increase the likelihood of clinical trial success, and would generate cutting-edge tools for the use in ongoing and future trials.

Progress

Timeline

Type

Target Life-stage

Validated (ACTB)
Ongoing (AMAP)
Assessment scale can be used in trials once properly validated
Observational research study
All stages

Interventional clinical study

A large amount of research has linked sleep with learning and memory development in infants and toddlers. Various sleep disturbances have been also observed in children with Ds. While napping is typical in infants and toddlers until the age of three, many with Ds continue to nap until they are about eight- years-old.

A possible link between napping behavior and learning and memory function has not been studied in those with Ds. Dr. Edgin suggests that nighttime sleep, which is critical for proper memory function, may be disturbed due to the increase in daytime napping. She, along with Dr. Cowen and Dr. Andrews-Hanna are conducting a “nap intervention” study among children with Ds.

Dr. Edgin and colleagues will work with parents to restrict daytime napping in children with Ds who are 3.5 years old. Then, they will measure nighttime sleep quality and administer memory games in the daytime to assess the children’s ability. If improvements are detected, this intervention could be easily implemented by parents at home.

Progress

Timeline

Type

Target Life-stage

Ongoing
In development, could be implemented as a guideline pending more validation research
Interventional clinical study
Adolescence