Back to resultsEffects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment
Primary Purpose
Cognitive Impairment, Mild
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Andrographis and Withania
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment, Mild focused on measuring Electroencephalography, Andrographis, Ashwagandha
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.
Sites / Locations
- Clinical Labors of NeuroCode AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Andrographis and Withania
Placebo
Arm Description
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
550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03780621
Brief Title
Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EuroPharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Mild
Keywords
Electroencephalography, Andrographis, Ashwagandha
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Andrographis and Withania
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate
Intervention Type
Dietary Supplement
Intervention Name(s)
Andrographis and Withania
Intervention Description
Combination of Andrographis paniculata and Withania somnifera
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Visually identical placebo capsule
Primary Outcome Measure Information:
Title
Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo
Description
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).
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Koch, MD
Organizational Affiliation
NeuroCode AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Labors of NeuroCode AG
City
Wetzlar
ZIP/Postal Code
D-35578
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment
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