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Safety Study of the Effect of Scelectium Tortuosum (as Zembrin®)in Aged Normals

NCT01805518 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-03-06

No results posted yet for this study

Summary

Phosphodiesterase is a candidate for the Rx \& prevention of cognitive and psychotic disorders. Since caffeine targets primarily PDE4(Phosphodiesterase subtype 4), caffeine analogs have been developed to mimic the actions of caffeine's ability to inhibit PDE-a, PDE4, PDE5 and adenosine-2 (AD-2)but are limited by the side effects of insomnia and heightened anxiety. Sildenafil (PDE-5 inhibitor) fails to enhance cognition in schizophrenia.

The study of PDE-4 in cognition in Alzheimer's dementia and schizophrenia has been done using the PDE-4 prototypal compound, rolipram, which improves cognition in rodents. Rolipram reverses the memory deficits induced by amyloid fragment Abeta25-35 and Abeta1-40 peptide. In humans the frequent side effect of vomiting hampers translational research. The clinical trial of rolipram in multiple sclerosis was terminated prematurely due to serious adverse events with paradoxical increases in MRI MS-specific brain lesions. However, PDE-4 remains paradigm for cognition.

Another strategy is chemical moieties capable of antagonizing the PDE-4 through allosteric modulation, rather than direct competitive inhibition hoping to minimize adverse events while retaining the biological potencies and functional responses of PDE-4 Modulators. Dietary supplements with PDE-4 effects have advantages in that small investments are needed to adequately study them.

Pharmacologically active chemicals of Sceletium species are mesembrine-type alkaloids that have proven PDE-4 activity. The PDE-4D knockout mice have enhanced memory function mediated through hippocampal neurogenesis via phosphorylated cAMP response element binding protein (pCREB) signaling.

This study purpose is to delineate the relationship of PDE-4 and cognition in normals. pCREB is possibly the putative biomarker of PDE-4 response with CREB as effector signaling pathway of PDE-4. CREB is close to nuclear receptors represented by BDNF (Brain Derived Neurotrophic Factor) and PPAR (Peroxisome Proliferator Activating Receptor) complexes. CREB changes in neuronal plasticity are targets for pharmacological paradigms for cognitive enhancement. This study will use the scelectium tortuosum as manufactured as Zembrin®. The findings in control subjects will form the basis for designing future studies of Zembrin® in neurodegenerative disorders with marked cognitive impairment such as Alzheimer's Dementia and Parkinson's Disease.

Conditions

  • Adverse Mental/Physical Effects of Low Dose S. Tortuosum.

Interventions

DIETARY_SUPPLEMENT

Scelectium Tortuosum

One arm has subjects 3 weeks on Scelectium Tortuosum 25gm po/d then 3 weeks off and then 3 weeks on Placebo. The other arm has subjects 3 weeks on placebo, then 3 weeks off and then 3 weeks on Scelectium Tortuosum 25mg po/d.

Sponsors & Collaborators

  • PL Thomas & Co., Inc.

    collaborator INDUSTRY

  • Woodbury, Michel, M.D.

    lead INDIV

Principal Investigators

  • Michel A Woodbury, MD · Woodbury, Michel

  • Simon Chiu, MD · Western University, Canada

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805518 on ClinicalTrials.gov