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Brain Aging in Phenylketonuria

Recruitingn/aAges 18 Years - anyAllInsel Gruppe AG, University Hospital Bern
NCT06969209 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Historically, the primary goal in managing phenylketonuria (PKU) has been to prevent severe and irreversible intellectual disability, as well as to address nutritional deficiencies that could lead to growth impairments or intellectual decline. Since the introduction of neonatal PKU screening in the mid-1960s, early treatment during childhood with a low phenylalanine diet or pharmacological interventions have been effective and prevent severe long-term sequelae. However, concerns persist that insufficient treatment during adulthood may cause subtle and, over time, possibly increasing cognitive and brain alterations. Recently, the first generation of early-treated patients has reached mid-adulthood. Hence, there is an urgent need to understand how PKU and metabolic control impact cognitive and brain aging and vice versa. The investigators preliminary cross-sectional findings su

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📋 Eligibility rules (as published)
Patients with PKU Inclusion Criteria: * Participation in PICO-Study and/or: * PKU diagnosed after a positive newborn screening * Treatment with Phe-restricted diet starting within the first 30 days of life * Age ≥18 years * Written informed consent Exclusion Criteria: * Patients with PKU not following a Phe-restricted diet within 6 months before the study * Phe concentration above 1600 µmol/L within 6 months before the study * Concomitant disease states suspected to significantly affect primary or secondary outcomes * Women who are pregnant or who are breast feeding * Conditions interfering with MRI such as magnetic (metallic) particles in the skull or brain, cardiac pacemaker, deep brain stimulators, cochlear implant, braces or permanent retainers Healthy controls Inclusion Criteria: * Age ≥18 years * Written informed consent Exclusion Criteria: * Concomitant disease states suspected to significantly affect primary or secondary outcomes * Women who are pregnant or who are breast feeding * Inability to follow the procedures of the study, e. g. due to language problems (lack of fluency in German or French), psychological disorders, dementia, etc. of the participant * Conditions interfering with MRI such as magnetic (metallic) particles in the skull or brain, cardiac pacemaker, deep brain stimulators, cochlear implant, braces or permanent retainers
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What it tests

  • Not listed
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Where

1 site
University Hospital Inselspital, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM)
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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