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

NCT03780621 | Completed Phase 1

• 1 other identifier: EP-1004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Electroencephalography; Andrographis; Ashwagandha

Outcome Measures

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

  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

Study Arms (2)

Andrographis and Withania

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Andrographis and Withania DIETARY_SUPPLEMENT

Combination of Andrographis paniculata and Withania somnifera

Andrographis and Withania

Placebo DIETARY_SUPPLEMENT

Visually identical placebo capsule

Placebo

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• EuroPharma, Inc.: lead

Study Sites (1)

Clinical Labors of NeuroCode AG

Wetzlar, D-35578, Germany

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Andrographis paniculata extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Klaus Koch, MD

  NeuroCode AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: April 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)