Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment
Study Details
Study Description
Brief Summary
A randomized, double-blind, placebo-controlled, two arm cross-over study to determine whether a specific combination of Andrographis paniculata and Withania somnifera can be regarded as a safe and effective treatment for cognitive deficits.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Andrographis and Withania Active ingredient: 550 mg of Andrographis paniculata (standardized to 40 mg andrographolides) and Withania somnifera (standardized to 10 mg withanolides) taken twice daily, once in the morning and once in the evening |
Dietary Supplement: Andrographis and Withania
Combination of Andrographis paniculata and Withania somnifera
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Placebo Comparator: Placebo 550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate |
Dietary Supplement: Placebo
Visually identical placebo capsule
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Outcome Measures
Primary Outcome Measures
- Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo [Four weeks]
Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during the test of cognitive performance: d2-test for attention (d2-Test), memory test (ME-Test), concentration-performance-test with financial reward (CPT-Test).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female volunteers suffering from cognitive deficits.
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Questionnaire-DemTect. "DemTect" (for pre-selection of subjects) - score values 8-12 are regarded as conclusive.
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Age between 60 and 75 years (both included).
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Subjects should be right-handed.
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Subject must be capable of giving informed consent.
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Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent).
Exclusion Criteria:
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Subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded.
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Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
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Clinically relevant allergic symptoms.
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Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history.
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Consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history.
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Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). Known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic).
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Presence of a rare, genetic disease such as fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency (anamnestic).
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Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day).
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Detection of alcohol at the time of initial examination as well as on day A, B, C and D (alcohol test).
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Smoking in the study center on study days A, B, C and D.
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Result of the DemTect Questionnaire score <8 or >12.
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Participation in another clinical trial within the last 60 days.
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Bad compliance.
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Cancellation of informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clinical Labors of NeuroCode AG | Wetzlar | Germany | D-35578 |
Sponsors and Collaborators
- EuroPharma, Inc.
Investigators
- Principal Investigator: Klaus Koch, MD, NeuroCode AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EP-1004