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Completed

NCT Number: NCT03780621

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

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Labors of NeuroCode AG

Wetzlar, D-35578, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Andrographis and Withania

Dietary Supplement

Combination of Andrographis paniculata and Withania somnifera

Placebo

Dietary Supplement

Visually identical placebo capsule

Primary outcomes

  1. Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

EuroPharma, Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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