Ammonia Levels and Cognitive Impairment

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02059356
• Other study ID #: Pro00048143
• Status: Terminated
• Phase: N/A
• First received: January 6, 2014
• Last updated: March 13, 2015
• Start date: January 2014

Study information

• Verified date: March 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• cognitive decline (suspected or documented)

• able to get blood drawn

Exclusion Criteria:

• liver disease/cirrhosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Decline
• Cognitive Impairment
• Dementia
• Developmental Delay

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood ammonia level		Baseline, Pretreatment and 3 months after treatment	No
Secondary	Change in mini-status examination		Prior to treatment and 3 months after treatment	No