Ammonia Levels and Cognitive Impairment

NCT ID: NCT02059356

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31

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.

Conditions

Dementia; Cognitive Decline; Cognitive Impairment; Developmental Delay

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-cirrhotic patients with cognitive impairment

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• cognitive decline (suspected or documented)
• able to get blood drawn

Exclusion Criteria

• liver disease/cirrhosis

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00048143

Identifier Type: -

Identifier Source: org_study_id