Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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Effects of an Adaptogenic Extract on Electrical Activity of Brain in Elderly Subjects With Cognitive Impairment: a Randomized, Double Blind, Placebo-controlled, Two Arms Cross-over Study.

Conditions
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Cognitive Impairment, Mild

Intervention / Treatment
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* Dietary Supplement: Andrographis and Withania
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female volunteers suffering from cognitive deficits. Questionnaire-DemTect. DemTect (for pre-selection of subjects) - score values 8-12 are regarded as conclusive. Age between 60 and 75 years (both included). Subjects should be right-handed. Subject must be capable of giving informed consent. Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent). Exclusion Criteria: Subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded. Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination. Clinically relevant allergic symptoms. Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history. 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. 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). Presence of a rare, genetic disease such as fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency (anamnestic). Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day). Detection of alcohol at the time of initial examination as well as on day A, B, C and D (alcohol test). Smoking in the study center on study days A, B, C and D. Result of the DemTect Questionnaire score <8 or >12. Participation in another clinical trial within the last 60 days. Bad compliance. Cancellation of informed consent.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Andrographis and Withania<br>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<br>* Combination of Andrographis paniculata and Withania somnifera<br>|
| Placebo Comparator: Placebo<br>550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate | Dietary Supplement: Placebo<br>* Visually identical placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo | 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). | Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroencephalography, Andrographis, Ashwagandha