HealthyPhase 2MemIprovNCT01647919
Effects of cogniVida™ on Learning and Memory and in Comparison to Placebo After Long-term Supplementation
A Phase 2 study testing cogniVida™ 100 mg/day in people with Healthy, run by dsm-firmenich Switzerland AG at 1 site in United Kingdom.
Trial summary
The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory performance (executive function, associative, spatial and verbal memory) as well as on mood and attention parameters after four, eight and eleven weeks of supplementation and in comparison with placebo. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cogniVida™ 100 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to May 2013
- Phase
- Phase 2
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or Females, age 50 - 65 years
- Subject agrees to maintain his or her habitual diet and physical activity patterns throughout the study period.
- Subject 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.
- Subject has a body mass index (BMI) of ≥18.5 and ≤ 30.00 kg/m2 at screening.
- Subject is willing to refrain from consuming alcoholic drinks 24 h prior to test days and until the end of each assessment period and refrain from consuming caffeine, and caffeine-containing products 12 h prior to test days and until the end of each assessment period.
- Subject is willing to refrain from vigorous physical activity 12 h prior to test days.
- Subject 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
- Subject has a positive drug screening of amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic antidepressants at screening or at any of the admission days.
- Subjects has a positive breath alcohol and breath carbon monoxide test at screening or at any of the admission days.
- Subject has abnormal clinical chemistry and hematology laboratory test results of clinical significance according to established criteria.
- Subjects with a history of renal or hepatic disease that is likely to interfere with the metabolism or excretion of the test product.
- Subject has donated more than 300 mL of blood during the three months prior to screening.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the average blood pressure measured at screening.
Show all 19Show fewer
- Subject has 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.
- Excessive habitual caffeine consumption (>500 mg caffeine/d), following screening and throughout the study period. Caffeine consumption will be assessed using the Caffeine Consumption Questionnaire
- Subjects who are on a significant hypocaloric diet (i.e. < 1200 calories per day) aiming for significant weight loss.
- Use of any sleep aid medication within four days prior to each test day (visits 2, 3, 4, 5; days 0, 28, 56, 77).
- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- Subject is pregnant, planning to be pregnant during the study period, lactating, or women who consider themselves to be of childbearing potential and who are engaged in an active sex life who are unwilling to commit to the use of an approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Use of any psychotropic medication within four weeks of visit 1, day -14 and throughout the study.
- Use of dietary supplements containing any of the following: lutein, ginkgo biloba, St. John's wort, ginseng, gotu kola (Indian pennywort); daily doses of vitamin E (≥30 mg/d) or folic acid (≥400 ug/d); thiamine, riboflavin, and/or pyridoxine (≥2 mg/d); and eicosapentaenoic acid (EPA), docosahexaenoic acid or a combination of EPA + DHA (≥500 mg/d) within 2 weeks prior to screening.
- Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit and throughout the study.
- Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units).
- Subject has a known allergy or sensitivity to study product or any ingredients of the study product or meals provided.
- The subject is unable to perform the tests on the COMPASS System during training to the established acceptable levels for participation in this type of study.
- Use of stevia extract sweetened products/drinks or stevia leaves within 1 month of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory performance (executive function, associative, spatial and verbal memory) as well as on mood and attention parameters after four, eight and eleven weeks of supplementation and in comparison with placebo.
cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The investigators do not claim that this supplement is meant to treat any ailment.
- Conditions
- Healthy
- Being tested
- cogniVida™ 100 mg/day, Placebo
- Keywords
- Cognition, Attention, Memory, Mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cogniVida™ 100 mg/dayDietary supplement
4 capsules 25 mg (total 100 mg) cogniVida™ once a day
PlaceboDietary supplement
4 capsules of placebo identical to cogniVida™ once a day
| Study group | Role | What they receive |
|---|---|---|
| cogniVida™ 100 mg/day | Experimental | Not described Receives: Dietary Supplement: cogniVida™ 100 mg/day |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associative / Visual Memory (Name to Face Recall (COMPASS))
Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 1 month
Measured: Day 0 (baseline) to day 28
Associative / Visual Memory (Name to Face Recall (COMPASS))
Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 2 months
Measured: Day 0 (baseline) to day 56
Associative / Visual Memory (Name to Face Recall (COMPASS))
Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 3 months
Measured: Day 0 (baseline) to day 77
Visual Memory (Picture Recognition (COMPASS))
Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 1 month
Measured: Day 0 (baseline) to day 28
Visual Memory (Picture Recognition (COMPASS))
Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 2 months
Measured: Day 0 (baseline) to day 56
Visual Memory (Picture Recognition (COMPASS))
Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 3 months
Measured: Day 0 (baseline) to day 77
Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 1 month
Measured: Day 0 (baseline) to day 28
Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 2 months
Measured: Day 0 (baseline) to day 56
Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 3 months
Measured: Day 0 (baseline) to day 77
Working and Spatial Memory ('Corsi Blocks'(COMPASS))
Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 1 month
Measured: Day 0 (baseline) to day 28
Working and Spatial Memory ('Corsi Blocks'(COMPASS))
Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 2 months
Measured: Day 0 (baseline) to day 56
Working and Spatial Memory ('Corsi Blocks'(COMPASS))
Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 3 months
Measured: Day 0 (baseline) to day 77
Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 1 month
Measured: Day 0 (baseline) to day 28
Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 2 months
Measured: Day 0 (baseline) to day 56
Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 3 months
Measured: Day 0 (baseline) to day 77
Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 1 month
Measured: Day 0 (baseline) to day 28
Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 2 months
Measured: Day 0 (baseline) to day 56
Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 3 months
Measured: Day 0 (baseline) to day 77
Secondary outcomes (15)
Attention and Concentration (Choice Reaction Time (COMPASS))
Attention and Concentration Tasks on a computer. Outcome measurement:
Change of speed of response from baseline to 1 month.
Measured: Day 0 (baseline) to day 28
Attention and Concentration (Choice Reaction Time (COMPASS))
Attention and Concentration Tasks on a computer. Outcome measurement:
Change of speed of response from baseline to 2 months.
Measured: Day 0 (baseline) to day 56
Attention and Concentration (Choice Reaction Time (COMPASS))
Attention and Concentration Tasks on a computer. Outcome measurement:
Change of speed of response from baseline to 3 months.
Measured: Day 0 (baseline) to day 77
Attention and Concentration (Rapid Visual Information Processing (COMPASS))
Attention and Concentration Tasks on a computer. Outcome measurement:
Change of accuracy, false alarms, speed of response from baseline to 1 month.
Measured: Day 0 (baseline) to day 28
Attention and Concentration (Rapid Visual Information Processing (COMPASS))
Attention and Concentration Tasks on a computer. Outcome measurement:
Change of accuracy, false alarms, speed of response from baseline to 2 months.
Measured: Day 0 (baseline) to day 56
Attention and Concentration (Rapid Visual Information Processing (COMPASS))
Attention and Concentration Tasks on a computer. Outcome measurement:
Change of accuracy, false alarms, speed of response from baseline to 3 months.
Measured: Day 0 (baseline) to day 77
Bond-Lader Visual Analog Scales (VAS) of Mood
This questionnaire of 16 analogue scales derives three factors that assess change in self-rated alertness, self-rated calmness and self-rated contentment. (presented within COMPASS) Outcome measurement: Change of these parameters from baseline to 1 month.
Measured: Day 0 (baseline) to day 28
Bond-Lader Visual Analog Scales (VAS) of Mood
This questionnaire of 16 analogue scales derives three factors that assess change in self-rated alertness, self-rated calmness and self-rated contentment. (presented within COMPASS) Outcome measurement: Change of these parameters from baseline to 2 months.
Measured: Day 0 (baseline) to day 56
Bond-Lader Visual Analog Scales (VAS) of Mood
This questionnaire of 16 analogue scales derives three factors that assess change in self-rated alertness, self-rated calmness and self-rated contentment. (presented within COMPASS) Outcome measurement: Change of these parameters from baseline to 3 months.
Measured: Day 0 (baseline) to day 77
Profile of Mood States (POMS) Questionnaire
The POMS provides scales of tension-anxiety, depression-dejection, anger
-hostility, vigor-activity, fatigue-inertia and confusion-bewilderment. A score will be obtained from each and a single score of "mood disturbance" will be computed. (paper and pencil) Outcome measurement: Change of these parameters from baseline to 1 month.
Measured: Day 0 (baseline) to day 28
Profile of Mood States (POMS) Questionnaire
The POMS provides scales of tension-anxiety, depression-dejection, anger
-hostility, vigor-activity, fatigue-inertia and confusion-bewilderment. A score will be obtained from each and a single score of "mood disturbance" will be computed. (paper and pencil) Outcome measurement: Change of these parameters from baseline to 2 months.
Measured: Day 0 (baseline) to day 56
Profile of Mood States (POMS) Questionnaire
The POMS provides scales of tension-anxiety, depression-dejection, anger
-hostility, vigor-activity, fatigue-inertia and confusion-bewilderment. A score will be obtained from each and a single score of "mood disturbance" will be computed. (paper and pencil) Outcome measurement: Change of these parameters from baseline to 3 months.
Measured: Day 0 (baseline) to day 77
Prospective and Retrospective Memory Questionnaire (PRMQ)
Subjects will be asked about their subjective 'prospective' and 'retrospective' memory performance - paper and pencil Outcome measurement: Change of memory scores from baseline to 1 month.
Measured: Day 0 (baseline) to day 28
Prospective and Retrospective Memory Questionnaire (PRMQ)
Subjects will be asked about their subjective 'prospective' and 'retrospective' memory performance - paper and pencil Outcome measurement: Change of memory scores from baseline to 2 months.
Measured: Day 0 (baseline) to day 56
Prospective and Retrospective Memory Questionnaire (PRMQ)
Subjects will be asked about their subjective 'prospective' and 'retrospective' memory performance - paper and pencil Outcome measurement: Change of memory scores from baseline to 3 months.
Measured: Day 0 (baseline) to day 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kennedy, Prof, Principal investigator, Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UKCrystal Haskell, PhD, Principal investigator, Associate Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647919
- Sponsor's protocol ID
- 2012-01-10-STEV
- Acronym
- MemIprov
- Status last verified
- Aug 2013
- First submitted
- 22 Jun 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of cogniVida™ on Learning and Memory and in Comparison to Placebo After Long-term Supplementation
- ClinicalTrials.gov ID
- NCT01647919
- Acronym / sponsor ID
- MemIprov / 2012-01-10-STEV
- Conditions
- Healthy
- Keywords
- Cognition, Attention, Memory, Mood
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Jul 2012 (estimated)
- 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.
The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory performance (executive function, associative, spatial and verbal memory) as well as on mood and attention parameters after four, eight and eleven weeks of supplementation and in comparison with placebo.
cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The investigators do not claim that this supplement is meant to treat any ailment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cogniVida™ 100 mg/day | Experimental | Dietary Supplement: cogniVida™ 100 mg/day |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or Females, age 50 - 65 years
- Subject agrees to maintain his or her habitual diet and physical activity patterns throughout the study period.
- Subject 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.
- Subject has a body mass index (BMI) of ≥18.5 and ≤ 30.00 kg/m2 at screening.
- Subject is willing to refrain from consuming alcoholic drinks 24 h prior to test days and until the end of each assessment period and refrain from consuming caffeine, and caffeine-containing products 12 h prior to test days and until the end of each assessment period.
Key exclusion criteria (19 listed)
- Subject has a positive drug screening of amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic antidepressants at screening or at any of the admission days.
- Subjects has a positive breath alcohol and breath carbon monoxide test at screening or at any of the admission days.
- Subject has abnormal clinical chemistry and hematology laboratory test results of clinical significance according to established criteria.
- Subjects with a history of renal or hepatic disease that is likely to interfere with the metabolism or excretion of the test product.
- Subject has donated more than 300 mL of blood during the three months prior to screening.
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 |
|---|---|---|
| cogniVida™ 100 mg/day4 capsules 25 mg (total 100 mg) cogniVida™ once a day | Dietary supplement | cogniVida™ 100 mg/day |
| Placebo4 capsules of placebo identical to cogniVida™ once a day | Dietary supplement | Placebo |
Primary outcome
Associative / Visual Memory (Name to Face Recall (COMPASS))
Time frame: Day 0 (baseline) to day 28
Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 1 month
Associative / Visual Memory (Name to Face Recall (COMPASS))
Time frame: Day 0 (baseline) to day 56
Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 2 months
Associative / Visual Memory (Name to Face Recall (COMPASS))
Time frame: Day 0 (baseline) to day 77
Associative / Visual Memory Task on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 3 months
Visual Memory (Picture Recognition (COMPASS))
Time frame: Day 0 (baseline) to day 28
Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 1 month
Visual Memory (Picture Recognition (COMPASS))
Time frame: Day 0 (baseline) to day 56
Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 2 months
Visual Memory (Picture Recognition (COMPASS))
Time frame: Day 0 (baseline) to day 77
Visual Memory Tasks on a computer: Outcome measurement: Change in percent correct from baseline measurement to 3 months
Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
Time frame: Day 0 (baseline) to day 28
Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 1 month
Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
Time frame: Day 0 (baseline) to day 56
Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 2 months
Working and Spatial Memory ('Sternberg' Numeric Working Memory task (COMPASS))
Time frame: Day 0 (baseline) to day 77
Working and Spatial Memory Tasks on a computer. Outcome measurements: Change of speed and accuracy of performance from baseline measurement to 3 months
Working and Spatial Memory ('Corsi Blocks'(COMPASS))
Time frame: Day 0 (baseline) to day 28
Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 1 month
Working and Spatial Memory ('Corsi Blocks'(COMPASS))
Time frame: Day 0 (baseline) to day 56
Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 2 months
Working and Spatial Memory ('Corsi Blocks'(COMPASS))
Time frame: Day 0 (baseline) to day 77
Working and Spatial Memory Tasks on a computer. Outcome measurement: Change of span score from baseline measurement to 3 months
Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
Time frame: Day 0 (baseline) to day 28
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 1 month
Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
Time frame: Day 0 (baseline) to day 56
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 2 months
Executive Function and Verbal Memory (Peg and Ball Task (COMPASS))
Time frame: Day 0 (baseline) to day 77
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy, thinking time and speed of performance from baseline measurement to 3 months
Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
Time frame: Day 0 (baseline) to day 28
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 1 month
Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
Time frame: Day 0 (baseline) to day 56
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 2 months
Executive Function and Verbal Memory (Delayed Word Recognition (COMPASS))
Time frame: Day 0 (baseline) to day 77
Executive Function and Verbal Memory Tasks on a computer. Outcome measurements: Change of accuracy and speed of response from baseline measurement to 3 months
15 secondary outcomes
Attention and Concentration (Choice Reaction Time (COMPASS))
Time frame: Day 0 (baseline) to day 28
Attention and Concentration (Choice Reaction Time (COMPASS))
Time frame: Day 0 (baseline) to day 56
Attention and Concentration (Choice Reaction Time (COMPASS))
Time frame: Day 0 (baseline) to day 77
Attention and Concentration (Rapid Visual Information Processing (COMPASS))
Time frame: Day 0 (baseline) to day 28
Attention and Concentration (Rapid Visual Information Processing (COMPASS))
Time frame: Day 0 (baseline) to day 56
Attention and Concentration (Rapid Visual Information Processing (COMPASS))
Time frame: Day 0 (baseline) to day 77
Bond-Lader Visual Analog Scales (VAS) of Mood
Time frame: Day 0 (baseline) to day 28
Bond-Lader Visual Analog Scales (VAS) of Mood
Time frame: Day 0 (baseline) to day 56
Bond-Lader Visual Analog Scales (VAS) of Mood
Time frame: Day 0 (baseline) to day 77
Profile of Mood States (POMS) Questionnaire
Time frame: Day 0 (baseline) to day 28
Profile of Mood States (POMS) Questionnaire
Time frame: Day 0 (baseline) to day 56
Profile of Mood States (POMS) Questionnaire
Time frame: Day 0 (baseline) to day 77
Prospective and Retrospective Memory Questionnaire (PRMQ)
Time frame: Day 0 (baseline) to day 28
Prospective and Retrospective Memory Questionnaire (PRMQ)
Time frame: Day 0 (baseline) to day 56
Prospective and Retrospective Memory Questionnaire (PRMQ)
Time frame: Day 0 (baseline) to day 77
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 7 Aug 2013.
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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.
David Kennedy, Prof principal investigator
Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK
Crystal Haskell, PhD principal investigator
Associate Director of the 'Brain, Performance and Nutrition Research Centre', Northumbria University, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cogniVida™ 100 mg/day in people with Healthy, run by dsm-firmenich Switzerland AG at 1 site in United Kingdom.
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 7 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 7 Aug 2013. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Associative / Visual Memory (Name to Face Recall (COMPASS)) (time frame: Day 0 (baseline) to day 28). The study lists 18 primary outcomes in all. 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 7 Aug 2013.