Ammonia Levels and Cognitive Impairment

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02059356
• Collaborator: (none)
• Enrollment: 17
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Cognitive Decline; Cognitive Impairment; Developmental Delay

Study Design

• Study Type: Observational
• Actual Enrollment: 17 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalence of High Ammonia Levels in Patients With Cognitive Impairment. Does Treatment Help?
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Non-cirrhotic patients with cognitive impairment

Outcome Measures

Primary Outcome Measures

1. Change in blood ammonia level [Baseline, Pretreatment and 3 months after treatment]

Secondary Outcome Measures

1. Change in mini-status examination [Prior to treatment and 3 months after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• cognitive decline (suspected or documented)

• able to get blood drawn

Exclusion Criteria:

• liver disease/cirrhosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Hospital	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02059356
• Other Study ID Numbers: Pro00048143
• First Posted: Feb 11, 2014
• Last Update Posted: Mar 17, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Duke University: Dementia; Alzheimer's; Alzheimers; Cognitive decline; Cognitive impairment; Memory loss; Memory disorder; Forgetfulness; Confusion; Senile; Demented; Developmental delay; Portal systemic shunting; High ammonia level; Elevated ammonia level
• Additional relevant MeSH terms: Dementia; Cognitive Dysfunction

Study Results

No Results Posted as of Mar 17, 2015