Status:
COMPLETED
Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment
Lead Sponsor:
EuroPharma, Inc.
Conditions:
Cognitive Impairment, Mild
Eligibility:
All Genders
60-75 years
Phase:
PHASE1
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03780621
Start Date
April 1 2019
End Date
June 1 2019
Last Update
November 14 2019
Active Locations (1)
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1
Clinical Labors of NeuroCode AG
Wetzlar, Germany, D-35578