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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Hindawi Limited
2014-01-01
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| Series: | Evidence-Based Complementary and Alternative Medicine |
| Online Access: | http://dx.doi.org/10.1155/2014/682014 |
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doaj-30c8c17a6c674e679420a17de71c903f2020-11-24T22:08:56ZengHindawi LimitedEvidence-Based Complementary and Alternative Medicine1741-427X1741-42882014-01-01201410.1155/2014/682014682014Proof-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 DementiaSimon Chiu0Nigel Gericke1Michel Farina-Woodbury2Vladimir Badmaev3Hana Raheb4Kristen Terpstra5Joalex Antongiorgi6Yves Bureau7Zack Cernovsky8Jirui Hou9Veronica Sanchez10Marissa Williams11John Copen12Mariwan Husni13Liz Goble14Lawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaMedical and Scientific of HG & H Pharmaceuticals (Pty) Ltd., 193 Bryanston Drive, Bryanston 2192, South AfricaDepartment of Psychiatry, School of Medicine, University of Puerto Rico, San Juan, PR 00936-5067, USAMedical and Scientific Affairs, P L Thomas & Co., Inc., Morristown, NJ 07960, USALawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaDepartment of Psychiatry, School of Medicine, University of Puerto Rico, San Juan, PR 00936-5067, USALawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaDepartment of Psychiatry, Island Medical Program, University of Victoria, University British Columbia Extended Medical Campus, Victoria, BC, V8W 2Y2, CanadaDepartment of Psychiatry, Northern Ontario School of Medicine, Thunder Bay, ON, P7B 5E1, CanadaLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, N6A 4V2, CanadaIntroduction. 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.http://dx.doi.org/10.1155/2014/682014 |
| collection |
DOAJ |
| language |
English |
| format |
Article |
| sources |
DOAJ |
| author |
Simon Chiu Nigel Gericke Michel Farina-Woodbury Vladimir Badmaev Hana Raheb Kristen Terpstra Joalex Antongiorgi Yves Bureau Zack Cernovsky Jirui Hou Veronica Sanchez Marissa Williams John Copen Mariwan Husni Liz Goble |
| spellingShingle |
Simon Chiu Nigel Gericke Michel Farina-Woodbury Vladimir Badmaev Hana Raheb Kristen Terpstra Joalex Antongiorgi Yves Bureau Zack Cernovsky Jirui Hou Veronica Sanchez Marissa Williams John Copen Mariwan Husni Liz Goble 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 Evidence-Based Complementary and Alternative Medicine |
| author_facet |
Simon Chiu Nigel Gericke Michel Farina-Woodbury Vladimir Badmaev Hana Raheb Kristen Terpstra Joalex Antongiorgi Yves Bureau Zack Cernovsky Jirui Hou Veronica Sanchez Marissa Williams John Copen Mariwan Husni Liz Goble |
| author_sort |
Simon Chiu |
| 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_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_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_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 |
| publisher |
Hindawi Limited |
| series |
Evidence-Based Complementary and Alternative Medicine |
| issn |
1741-427X 1741-4288 |
| publishDate |
2014-01-01 |
| 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. |
| url |
http://dx.doi.org/10.1155/2014/682014 |
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