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

Cognitive Impairment, Mild Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780621
• Other study ID #: EP-1004
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: November 2019
• Source: EuroPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

Dietary Supplement:
• Andrographis and Withania
Combination of Andrographis paniculata and Withania somnifera
• Placebo
Visually identical placebo capsule

Locations

Country	Name	City	State
Germany	Clinical Labors of NeuroCode AG	Wetzlar

Sponsors (1)

Lead Sponsor	Collaborator
EuroPharma, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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