Memory DysfunctionNCT03198936
To Access the Effect of Brain Pill™ on Working Memory Capacity and Mood Behaviour.
A study testing Cognizin® SynapsaTM in people with Memory Dysfunction and Mood Disorders, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Dysfunction, Mood Disorders
- What is being tested?
- Cognizin® SynapsaTM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 11 Apr 2017to 15 Mar 2018
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with Mini-Mental State Examination (MMSE) score > 23 indicating a healthy cognitive state.
- Subjects with Adult Memory Questionnaire (AMQ) score of 40-70% indicating subjective memory lapse.
- Subjects with T score on 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form: 50.0-59.9 (mild) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) criteria.
- Males and Females of Age 18 - 60 years will be selected for the study.
- Subject who is willing to maintain his or her habitual diet and usual physical activity patterns throughout the study.
- Subject who has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
Show all 11Show fewer
- Subject should be willing to refrain from consuming alcohol 24 h prior to the test days.
- Subject should be willing to refrain from consuming caffeine and caffeine-containing products 12 h prior to test days.
- Subject should be willing to refrain from vigorous physical activity 12 h prior to test days.
- Subject should be a non-smoker.
- Subject who understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subjects with MMSE score ≤ 23 indicative of clinical dementia.
- Subjects with AMQ score <40 and >70 %.
- T score on 8-item PROMIS Depression Short Form <50 (normal) and ≥60 (moderate and severe).
- Confirmed diagnosis of dementia/ Alzheimer's disease.
- Current evidence of hearing impairment or other information processing impairment.
- Subjects who are using amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic antidepressants, as disclosed at the screening visit.
Show all 19Show fewer
- Subjects with uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the average blood pressure measured at the screening.
- Subjects with a history or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
- Subject with a history, in the judgment of the Investigator, of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study or which could significantly influence cognitive abilities.
- Use of any sleep aid medication.
- Pregnant female subjects or planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Excessive habitual caffeine consumption (>300 mg caffeine/d or ≥3 cups of caffeinated coffee/d), following screening and throughout the study period.
- Use of any psychotropic medication within four weeks of screening and throughout the study.
- Use of antibiotics or signs of active systemic infection. Treatment visits will be rescheduled to allow the subject to wash off of the antibiotic for at least five days prior to any test visit.
- Subject who has had exposure to any non-registered drug product within 30 days prior to the screening visit.
- Subjects who are using any dietary supplements and or containing any of the ingredients of the investigational product.
- Recent history of (within 12 months of screening visit 1) or strong potential for alcohol or substance abuse.(Alcohol abuse is defined as >14 drinks per week.)
- Subject who has a known allergy or sensitivity to the study product or any ingredients of the study product or meals provided.
- The subject is unable to perform the tests on the computer for participation in this type of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Brain Pill™ on Working Memory Capacity and Mood Behaviour in Healthy Adults With Subjective Memory Complains and Mild Mood Disturbances.
Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement.
Read the detailed description
Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement with a balanced composition of scientifically proven nutrients for accelerating and restoring brain function and thereby enhancing the cognitive performance and creating positive impact on behavioral outcomes.Hence the aim of the study is assessment of the effects of Brain Pill supplementation on memory performance in healthy adults with subjective memory complaints.
It is a double-blind, randomized, placebo-controlled , single centered study to access the efficacy of Brain Pill on working memory capacity and mild mood disturbances.
Effect of Brain Pill on working memory capacity will be accessed by improvement in mean response time and accuracy measured by working memory battery from baseline to end of the study. Effect of Brain Pill is also accessed on Neurophysiological improvement in working memory as measured by electroencephelogram (EEG) from baseline to end of the study. Also improvement in attention and concentration will be accessed from baseline to end of the study by Picture recognition test.
Effect of Brain Pill on mood disturbances will be accessed by Brunel Universal Mood State.
- Conditions
- Memory Dysfunction, Mood Disorders
- Being tested
- Cognizin® SynapsaTM, Placebo
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognizin® SynapsaTMDietary supplement
2 capsules to be taken twice a day with meals with a glassful of water
PlaceboDietary supplement
2 capsules to be taken twice a day with meals with glassful of water
| Study group | Role | What they receive |
|---|---|---|
| Cognizin® SynapsaTM | Experimental | Dose - 2 capsules twice a day with meals Receives: Dietary Supplement: Cognizin® SynapsaTM |
| Placebo | Placebo comparator | Matching placebo capsules with microcrystalline cellulose with added colours Dose - 2 capsules twice a day with meals Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory Capacity
To evaluate effect of Brain Pill™ on working memory capacity as improvement in mean response time and accuracy and measured by working memory battery.
Measured: 84 days
Secondary outcomes (2)
Attention and Concentration
To evaluate effect of Brain Pill™ on attention and concentration as measured by Picture recognition test (PRT).
Measured: 84 days
Improvement in Mood Disturbances
To evaluate effect of Brain Pill™ on mood disturbances as measured by Brunel Universal Mood States (BRUMS).
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start11 Apr 2017
- Primary completion17 Nov 2017
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DysfunctionStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leading Edge Marketing LTD.
- Responsible party
- Sponsor
- Investigators
- Divya Patel, BSc, Study chair, Affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198936
- Sponsor's protocol ID
- LM/161103/BP/MCI
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2017
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brain Pill™ on Working Memory Capacity and Mood Behaviour in Healthy Adults With Subjective Memory Complains and Mild Mood Disturbances.
- ClinicalTrials.gov ID
- NCT03198936
- Acronym / sponsor ID
- LM/161103/BP/MCI
- Conditions
- Memory Dysfunction, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Leading Edge Marketing LTD.
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 26 Jun 2017 (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.
Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement.
Detailed description
Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement with a balanced composition of scientifically proven nutrients for accelerating and restoring brain function and thereby enhancing the cognitive performance and creating positive impact on behavioral outcomes.Hence the aim of the study is assessment of the effects of Brain Pill supplementation on memory performance in healthy adults with subjective memory complaints.
It is a double-blind, randomized, placebo-controlled , single centered study to access the efficacy of Brain Pill on working memory capacity and mild mood disturbances.
Effect of Brain Pill on working memory capacity will be accessed by improvement in mean response time and accuracy measured by working memory battery from baseline to end of the study. Effect of Brain Pill is also accessed on Neurophysiological improvement in working memory as measured by electroencephelogram (EEG) from baseline to end of the study. Also improvement in attention and concentration will be accessed from baseline to end of the study by Picture recognition test.
Effect of Brain Pill on mood disturbances will be accessed by Brunel Universal Mood State.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognizin® SynapsaTM | Experimental | Dietary Supplement: Cognizin® SynapsaTMDose - 2 capsules twice a day with meals |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatching placebo capsules with microcrystalline cellulose with added colours Dose - 2 capsules twice a day with meals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects with Mini-Mental State Examination (MMSE) score > 23 indicating a healthy cognitive state.
- Subjects with Adult Memory Questionnaire (AMQ) score of 40-70% indicating subjective memory lapse.
- Subjects with T score on 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form: 50.0-59.9 (mild) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) criteria.
- Males and Females of Age 18 - 60 years will be selected for the study.
- Subject who is willing to maintain his or her habitual diet and usual physical activity patterns throughout the study.
Key exclusion criteria (19 listed)
- Subjects with MMSE score ≤ 23 indicative of clinical dementia.
- Subjects with AMQ score <40 and >70 %.
- T score on 8-item PROMIS Depression Short Form <50 (normal) and ≥60 (moderate and severe).
- Confirmed diagnosis of dementia/ Alzheimer's disease.
- Current evidence of hearing impairment or other information processing impairment.
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 |
|---|---|---|
| Cognizin® SynapsaTM2 capsules to be taken twice a day with meals with a glassful of water | Dietary supplement | Cognizin® SynapsaTM |
| Placebo2 capsules to be taken twice a day with meals with glassful of water | Dietary supplement | Placebo |
Primary outcome
Working Memory Capacity
Time frame: 84 days
To evaluate effect of Brain Pill™ on working memory capacity as improvement in mean response time and accuracy and measured by working memory battery.
2 secondary outcomes
Attention and Concentration
Time frame: 84 days
Improvement in Mood Disturbances
Time frame: 84 days
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 12 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Memory Dysfunction
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Active, not recruitingObservational study
PAMNEU - Memory in Neurology
Cognitive Impairment
Active, not recruitingObservational study
PAPSY - Memory in Psychiatry
Cognitive Impairment
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.
Divya Patel, BSc study chair
Affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognizin® SynapsaTM in people with Memory Dysfunction and Mood Disorders, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
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 11 inclusion and 19 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 12 Apr 2021. 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 India. 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.
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?
Working Memory Capacity (time frame: 84 days). 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 12 Apr 2021.