Ammonia Levels and Cognitive Impairment

NCT02059356 | Terminated

• 1 other identifier: Pro00048143
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in blood ammonia level

  Baseline, Pretreatment and 3 months after treatment

Secondary Outcomes (1)

• Change in mini-status examination

  Prior to treatment and 3 months after treatment

Study Arms (1)

Non-cirrhotic patients with cognitive impairment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of assisted living center or the general public

You may qualify if:

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

You may not qualify if:

• liver disease/cirrhosis

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Learning Disabilities; Memory Disorders; Confusion; Hyperammonemia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: February 11, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (1)