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Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer's Dementia

Introduction. Converging evidence suggests that PDE-4 (phosphodiesterase subtype 4) plays a crucial role in regulating cognition via the PDE-4-cAMP cascade signaling involving phosphorylated cAMP response element binding protein (CREB). Objective. The primary endpoint was to examine the neurocogniti...

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Autores principales: Chiu, Simon, Gericke, Nigel, Farina-Woodbury, Michel, Badmaev, Vladimir, Raheb, Hana, Terpstra, Kristen, Antongiorgi, Joalex, Bureau, Yves, Cernovsky, Zack, Hou, Jirui, Sanchez, Veronica, Williams, Marissa, Copen, John, Husni, Mariwan, Goble, Liz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4217361/
https://www.ncbi.nlm.nih.gov/pubmed/25389443
http://dx.doi.org/10.1155/2014/682014
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author Chiu, Simon
Gericke, Nigel
Farina-Woodbury, Michel
Badmaev, Vladimir
Raheb, Hana
Terpstra, Kristen
Antongiorgi, Joalex
Bureau, Yves
Cernovsky, Zack
Hou, Jirui
Sanchez, Veronica
Williams, Marissa
Copen, John
Husni, Mariwan
Goble, Liz
author_facet Chiu, Simon
Gericke, Nigel
Farina-Woodbury, Michel
Badmaev, Vladimir
Raheb, Hana
Terpstra, Kristen
Antongiorgi, Joalex
Bureau, Yves
Cernovsky, Zack
Hou, Jirui
Sanchez, Veronica
Williams, Marissa
Copen, John
Husni, Mariwan
Goble, Liz
author_sort Chiu, Simon
collection PubMed
description Introduction. Converging evidence suggests that PDE-4 (phosphodiesterase subtype 4) plays a crucial role in regulating cognition via the PDE-4-cAMP cascade signaling involving phosphorylated cAMP response element binding protein (CREB). Objective. The primary endpoint was to examine the neurocognitive effects of extract Sceletium tortuosum (Zembrin) and to assess the safety and tolerability of Zembrin in cognitively healthy control subjects. Method. We chose the randomized double-blind placebo-controlled cross-over design in our study. We randomized normal healthy subjects (total n = 21) to receive either 25 mg capsule Zembrin or placebo capsule once daily for 3 weeks, in a randomized placebo-controlled 3-week cross-over design. We administered battery of neuropsychological tests: CNS Vital Signs and Hamilton depression rating scale (HAM-D) at baseline and regular intervals and monitored side effects with treatment emergent adverse events scale. Results. 21 subjects (mean age: 54.6 years ± 6.0 yrs; male/female ratio: 9/12) entered the study. Zembrin at 25 mg daily dosage significantly improved cognitive set flexibility (P < 0.032) and executive function (P < 0.022), compared with the placebo group. Positive changes in mood and sleep were found. Zembrin was well tolerated. Conclusion. The promising cognitive enhancing effects of Zembrin likely implicate the PDE-4-cAMP-CREB cascade, a novel drug target in the potential treatment of early Alzheimer's dementia. This trial is registered with ClinicalTrials.gov NCT01805518.
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spelling pubmed-42173612014-11-11 Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer's Dementia Chiu, Simon Gericke, Nigel Farina-Woodbury, Michel Badmaev, Vladimir Raheb, Hana Terpstra, Kristen Antongiorgi, Joalex Bureau, Yves Cernovsky, Zack Hou, Jirui Sanchez, Veronica Williams, Marissa Copen, John Husni, Mariwan Goble, Liz Evid Based Complement Alternat Med Research Article Introduction. Converging evidence suggests that PDE-4 (phosphodiesterase subtype 4) plays a crucial role in regulating cognition via the PDE-4-cAMP cascade signaling involving phosphorylated cAMP response element binding protein (CREB). Objective. The primary endpoint was to examine the neurocognitive effects of extract Sceletium tortuosum (Zembrin) and to assess the safety and tolerability of Zembrin in cognitively healthy control subjects. Method. We chose the randomized double-blind placebo-controlled cross-over design in our study. We randomized normal healthy subjects (total n = 21) to receive either 25 mg capsule Zembrin or placebo capsule once daily for 3 weeks, in a randomized placebo-controlled 3-week cross-over design. We administered battery of neuropsychological tests: CNS Vital Signs and Hamilton depression rating scale (HAM-D) at baseline and regular intervals and monitored side effects with treatment emergent adverse events scale. Results. 21 subjects (mean age: 54.6 years ± 6.0 yrs; male/female ratio: 9/12) entered the study. Zembrin at 25 mg daily dosage significantly improved cognitive set flexibility (P < 0.032) and executive function (P < 0.022), compared with the placebo group. Positive changes in mood and sleep were found. Zembrin was well tolerated. Conclusion. The promising cognitive enhancing effects of Zembrin likely implicate the PDE-4-cAMP-CREB cascade, a novel drug target in the potential treatment of early Alzheimer's dementia. This trial is registered with ClinicalTrials.gov NCT01805518. Hindawi Publishing Corporation 2014 2014-10-19 /pmc/articles/PMC4217361/ /pubmed/25389443 http://dx.doi.org/10.1155/2014/682014 Text en Copyright © 2014 Simon Chiu et al. https://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Chiu, Simon
Gericke, Nigel
Farina-Woodbury, Michel
Badmaev, Vladimir
Raheb, Hana
Terpstra, Kristen
Antongiorgi, Joalex
Bureau, Yves
Cernovsky, Zack
Hou, Jirui
Sanchez, Veronica
Williams, Marissa
Copen, John
Husni, Mariwan
Goble, Liz
Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer's Dementia
title Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer's Dementia
title_full Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer's Dementia
title_fullStr Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer's Dementia
title_full_unstemmed Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer's Dementia
title_short Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer's Dementia
title_sort proof-of-concept randomized controlled study of cognition effects of the proprietary extract sceletium tortuosum (zembrin) targeting phosphodiesterase-4 in cognitively healthy subjects: implications for alzheimer's dementia
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4217361/
https://www.ncbi.nlm.nih.gov/pubmed/25389443
http://dx.doi.org/10.1155/2014/682014
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