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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment, Mild
• Intervention / Treatment: Dietary supplement: Andrographis and Withania; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Wetzlar, Germany, D-35578
    • Clinical Labors of NeuroCode AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EuroPharma, Inc.
• Investigators: Principal Investigator: Klaus Koch, MD, NeuroCode AG

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Electroencephalography; Andrographis; Ashwagandha
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Andrographolide
• Other Study ID Numbers: EP-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No