Clinical trial NCT03780621: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Impairment, Mild
Keywords: Electroencephalography
Andrographis
Ashwagandha
Lead sponsor: EuroPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wetzlar
country: Germany
facility: Clinical Labors of NeuroCode AG
Study officials:
affiliation: NeuroCode AG
name: Klaus Koch, MD
role: PRINCIPAL_INVESTIGATOR
References: