Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria

Phenylketonurias Clinical Trial

Official title:

Kurzfristiger Einfluss Einer Guten Stoffwechseleinstellung Auf Kognitive Funktion, Wohlbefinden Und Stoffwechselparameter Bei Erwachsenen Patienten Mit Phenylketonurie (Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04210206
• Other study ID #: CoFu-PKU
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate if in adult patients with phenylketonuria (PKU) without strict metabolic control during the last 12 months, strict metabolic control for 8 weeks results in an improvement of cognitive function.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Men and women with classical PKU

• Age = 18 years

• Good metabolic control during childhood (at least until 12 years of age)

• Plasma Phe levels = 15 mg/dl for = 1 year

• Written informed consent prior to study participation

Exclusion Criteria:

• Reduced cognitive function (unability to perform test battery)

• Drug and or alcohol abuse

• Treatment with BH4

• Treatment with drugs known to affect cognitive function

Related Conditions & MeSH terms

• Phenylketonurias

Intervention

Other:
• PHE-diet
phenylalanine-restricted diet with phenylalanine free supplements for 8 weeks

Locations

Country	Name	City	State
Germany	University Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Klaus Parhofer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial working memory strategy index	cognitive function; scores range from 4 to 28, with lower scores representing better outcome	8 weeks
Secondary	Reaction time	cognitive function; milliseconds, with faster times representing better outcome	8 weeks
Secondary	Paired Associates Learning	cognitive function; scores range from 0 to 70, with lower scores indicating better outcome	8 weeks
Secondary	Multitasking Test	cognitive function; scores range from 0 to 279, with lower scores indicating better outcome	8 weeks