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

NCT ID: NCT03780621

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-06-01

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.

Conditions

Cognitive Impairment, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Andrographis and Withania

Intervention Type: DIETARY_SUPPLEMENT

Combination of Andrographis paniculata and Withania somnifera

Placebo

550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Visually identical placebo capsule

Interventions

Andrographis and Withania

Combination of Andrographis paniculata and Withania somnifera

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Visually identical placebo capsule

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EuroPharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Klaus Koch, MD

Role: PRINCIPAL_INVESTIGATOR

NeuroCode AG

Locations

Clinical Labors of NeuroCode AG

Wetzlar, , Germany

Countries

Germany

Other Identifiers

EP-1004

Identifier Type: -

Identifier Source: org_study_id