Clinical Trial: Ammonia Levels and Cognitive Impairment

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Prevalence of High Ammonia Levels in Patients With Cognitive Impairment. Does Treatment Help?

Brief Summary: The purpose and objective of this study is to determine the prevalence of elevated ammonia levels in subjects with cognitive impairment, and to observe if treating the cause of the elevated ammonia level improves mental status. This study does not include any imaging, treatment,or interventions, other than the blood draws. The blood draws will be taken to assess blood ammonia level and liver function. If the the ammonia level is not elevated, no further lab draws will occur. If the ammonia level is elevated, liver function is normal, and a cause for the high ammonia level is revealed with a plan for clinical treatment by the subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3 months after treatment. The main risk to subjects is related to the blood draw (i.e. momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a potential loss of confidentiality. A paired student t test will be done with the two later blood to compare objective data.

Detailed Summary:
Sponsor: Duke University

Current Primary Outcome: Change in blood ammonia level [ Time Frame: Baseline, Pretreatment and 3 months after treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in mini-status examination [ Time Frame: Prior to treatment and 3 months after treatment ]

Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: January 6, 2014
Date Started: January 2014
Date Completion:
Last Updated: March 13, 2015
Last Verified: March 2015