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A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits

NCT02778438 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2016-09-27

No results posted yet for this study

Summary

REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit.

Conditions

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Quintiles, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Shy, MD · Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02778438 on ClinicalTrials.gov