Skip to content

Ammonia Levels and Cognitive Impairment

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02059356
Enrollment
17
Registered
2014-02-11
Start date
2014-01-31
Completion date
Unknown
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Cognitive Impairment, Dementia, 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

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.

Interventions

None listed

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* liver disease/cirrhosis

Design outcomes

Primary

MeasureTime frame
Change in blood ammonia levelBaseline, Pretreatment and 3 months after treatment

Secondary

MeasureTime frame
Change in mini-status examinationPrior to treatment and 3 months after treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026