Evidence map›Paper›PMID 25389443›Full record

ArticleEvidence-based complementary and alternative medicine : eCAM2014

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.

Simon Chiu, Nigel Gericke, Michel Farina-Woodbury, Vladimir Badmaev, Hana Raheb, Kristen Terpstra, Joalex Antongiorgi, Yves Bureau, Zack Cernovsky, Jirui Hou and 5 more

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Evidence-based complementary and alternative medicine : eCAM, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01805518 (9 wk, Randomized, 2-blind, Placebo-controlled, 2X2 Cross-over Phase 1 Study of 25 mg of Scelectium Tortuosum), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01805518 phase1completednot on this map

9 wk, Randomized, 2-blind, Placebo-controlled, 2X2 Cross-over Phase 1 Study of 25 mg of Scelectium Tortuosum (as Zembrin®) in Aged Normals to Find Effects on Mental, Emotional and Cognitive Safety Measures and Cytokines.

TypeinterventionalSponsorWoodbury, Michel, M.D.Ran2011 to 2012Enrolled20ConditionsAdverse Mental/Physical Effects of Low Dose S. Tortuosum.ArmsScelectium Tortuosum
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. New Adenosine Derivatives fromMolecules (Basel, Switzerland) · 2021
    Article
  9. Article
  10. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 3 countries.

Simon ChiuLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2 ; Department of Psychiatry, University of Western Ontario, London, ON, Canada N6A 3K7.
Nigel GerickeMedical and Scientific of HG & H Pharmaceuticals (Pty) Ltd., 193 Bryanston Drive, Bryanston 2192, South Africa.ORCID 0000-0003-4212-1487
Michel Farina-WoodburyDepartment of Psychiatry, School of Medicine, University of Puerto Rico, San Juan, PR 00936-5067, USA.
Vladimir BadmaevMedical and Scientific Affairs, P L Thomas & Co., Inc., Morristown, NJ 07960, USA.ORCID 0000-0003-3737-2847
Hana RahebLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2.ORCID 0000-0001-5947-1075
Kristen TerpstraLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2.
Joalex AntongiorgiDepartment of Psychiatry, School of Medicine, University of Puerto Rico, San Juan, PR 00936-5067, USA.
Yves BureauLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2.
Zack CernovskyLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2 ; Department of Psychiatry, University of Western Ontario, London, ON, Canada N6A 3K7.
Jirui HouLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2.
Veronica SanchezLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2.
Marissa WilliamsLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2.
John CopenDepartment of Psychiatry, Island Medical Program, University of Victoria, University British Columbia Extended Medical Campus, Victoria, BC, Canada V8W 2Y2.
Mariwan HusniDepartment of Psychiatry, Northern Ontario School of Medicine, Thunder Bay, ON, Canada P7B 5E1.
Liz GobleLawson Health Research Institute, Lab FB125, 268 Grosvenor Street, London, ON, Canada N6A 4V2.
Lawson Health Research Institute · CAUniversity of Puerto Rico System · PRWestern University · CANOSM University · CAUniversity of Victoria · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Identifiers

PMID25389443
PMCPMC4217361
OpenAlexW2133874772

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.