drugset / Trial / NCT03788343
Phenylalanine and Its Impact on Cognition
Phase 4
Completed
90 enrolled
Insel Gruppe AG, University Hospital Bern
University of Zurich · collab
RandomizedCrossoverDouble-blindSupportive care
Summary
The PICO-Study is a randomized, placebo-controlled, crossover, non-inferiority trial conducted to add evidence to the current European treatment guidelines for adult patients with phenylketonuria.
Timeline
- Start
- 2019-08-19
- Primary completion
- 2022-06-17
- Completion
- 2022-06-17
Outcome
Met primary endpoint
paper For the primary endpoint, a 4-week increase of Phe intake was noninferior to placebo with respect to working memory accuracy PMID 38569786 ↗
Publications
- Maissen-Abgottspon S, Steiner L, Muri R, Wijesinghe D, Jann K, Morishima Y, Hochuli M, Kreis R, Trepp R, Everts R. Effect of a four-week oral Phe administration on neural activation and cerebral blood flow in adults with early-treated phenylketonuria. Neuroimage Clin. 2024;43:103654. doi: 10.1016/j.nicl.2024.103654. Epub 2024 Aug 14.
- Trepp R, Muri R, Maissen-Abgottspon S, Haynes AG, Hochuli M, Everts R. Cognition after a 4-week high phenylalanine intake in adults with phenylketonuria - a randomized controlled trial. Am J Clin Nutr. 2024 Apr;119(4):908-916. doi: 10.1016/j.ajcnut.2023.11.007. Epub 2024 Feb 9.
- Trepp R, Muri R, Abgottspon S, Bosanska L, Hochuli M, Slotboom J, Rummel C, Kreis R, Everts R. Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial. Trials. 2020 Feb 13;21(1):178. doi: 10.1186/s13063-019-4022-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Phenylalanine | Unknown | 1500 mg | Oral |
| Subject | Phenylalanine | Unknown | 2000 mg | Oral |
| Subject | Phenylalanine | Unknown | 2500 mg | Oral |
| Subject | Phenylalanine | Unknown | 3000 mg | Oral |