Cognitive Impairment, MildPhase 1NCT03780621
Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment
A Phase 1 study testing Andrographis and Withania in people with Cognitive Impairment, Mild, run by EuroPharma, Inc. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cognitive Impairment, Mild
- What is being tested?
- Andrographis and Withania
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 1 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Andrographis and Withania, Placebo
- Keywords
- Electroencephalography, Andrographis, Ashwagandha
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andrographis and WithaniaDietary supplement
Combination of Andrographis paniculata and Withania somnifera
PlaceboDietary supplement
Visually identical placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Apr 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuroPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Koch, MD, Principal investigator, NeuroCode AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780621
- Sponsor's protocol ID
- EP-1004
- Status last verified
- Nov 2019
- First submitted
- 14 Dec 2018
- Last updated
- 14 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03780621
- Acronym / sponsor ID
- EP-1004
- Conditions
- Cognitive Impairment, Mild
- Keywords
- Electroencephalography, Andrographis, Ashwagandha
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- EuroPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Andrographis and Withania | Experimental | Dietary Supplement: Andrographis and WithaniaActive 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 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andrographis and WithaniaCombination of Andrographis paniculata and Withania somnifera | Dietary supplement | Andrographis and Withania |
| PlaceboVisually identical placebo capsule | Dietary supplement | Placebo |
Primary outcome
Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo
Time frame: Four weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Koch, MD principal investigator
NeuroCode AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Andrographis and Withania in people with Cognitive Impairment, Mild, run by EuroPharma, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.