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

Sponsor
EuroPharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03780621
Collaborator
(none)
16
1
2
2
8

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
  • Dietary Supplement: Andrographis and Withania
  • Dietary Supplement: Placebo
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official 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.
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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

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

Outcome Measures

Primary Outcome Measures

  1. 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

Ages Eligible for Study:
60 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
EuroPharma, Inc.
ClinicalTrials.gov Identifier:
NCT03780621
Other Study ID Numbers:
  • EP-1004
First Posted:
Dec 19, 2018
Last Update Posted:
Nov 14, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EuroPharma, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2019