Breast CancerEarly Phase 1NCT01823991
COGNUTRIN in Breast Cancer Survivors
A Early Phase 1 study testing VitaBlue™ and Lovaza® in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to examine the safety and influence of an intervention (COGNUTRIN) using nutritional supplements (n-3 fatty acids and blueberry anthocyanins) on cognitive performance in breast cancer survivors following chemotherapy. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- VitaBlue™ and Lovaza®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2014to 2 May 2018
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases with Stage II-IIIA Breast Cancer that have completed adjuvant treatment with anthracyclines and/or taxanes + or -Radiation therapy within past 6 months(+/- 7 days) (subjects on concurrent endocrine therapy (TAM, Aromatase inhibitors are also eligible to participate as this is standard of care for this patient population)
- Able to understand and sign the informed consent
- Fluent in reading, comprehension and communication in the English language
- No evidence of dementia - Mini Mental State Examination (MMSE) >=23 but some evidence of cognitive impairment
- Must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts
- Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score >60%)
- Acceptable hemoglobin and hematocrit level based on complete blood count (CBC)
- Must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice
Who cannot join
- Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), androgens, Raloxifene or Tamoxifen during the previous 3 months
- Use of over the counter steroid hormonal supplements including dehydroepiandrosterone (DHEA)
- Patients with advanced or Stage IIIIB or IV breast cancer or other cancers
- Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial
- History of known allergy to components of the study supplements
- Renal or liver disease
Show all 12Show fewer
- Concurrent participation in another chemoprevention trial
- Evidence of bleeding diathesis or coagulopathy
- Metabolic abnormalities (e.g. thyroid disorders, insulin dependent diabetes, rheumatologic disease etc.)
- Known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit MRI imaging
- Medical history of concussions
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the potential participant inappropriate for entry into this study
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors
The purpose of this study is to examine the safety and influence of an intervention (COGNUTRIN) using nutritional supplements (n-3 fatty acids and blueberry anthocyanins) on cognitive performance in breast cancer survivors following chemotherapy. The investigators' goal is to treat or lessen the late effects of cancer treatment. The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.
Read the detailed description
This pilot study will evaluate the feasibility of administration of the nutritional supplement and placebo in this patient population and performing cognitive function testing at baseline and post supplementation.
This is a randomized, double-blind pilot study of COGNUTRIN vs. Placebo.
Participants have an equal chance (like flipping a coin) of being in either of the study groups. Neither the participant nor the study doctor will be able to choose which study group the participant is in. Participants will not know and the study doctor will not know which study group the participants are in.
- Conditions
- Breast Cancer
- Being tested
- VitaBlue™, Placebo, Lovaza®
- Keywords
- polyphenolics, anthocyanins, n-3 fatty acids
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaBlue™Drug
Also called blueberry (BB) Anthocyanins
Self administration of nutritional supplement COGNUTRIN for 3 months.
The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.
PlaceboOther
Self administration of placebo for 3 months.
Investigators use a placebo to make sure that it really is the study medicine that is making a difference in the participant's condition. It does not have anything in it that would normally help or harm most people.
Lovaza®Drug
Also called omega-3-acid ethyl esters
Self administration of nutritional supplement COGNUTRIN for 3 months.
The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.
| Study group | Role | What they receive |
|---|---|---|
| COGNUTRIN (VITABLUE and n-3 fatty acids) | Experimental | Participants will be provided with two bottles containing Lovaza and VitaBlue. Participants will be asked to take 1 tablet of Lovaza two times a day and 1 tablet of VitaBlue three times a day. Receives: Drug: VitaBlue™; Drug: Lovaza® |
| Placebo Administration | Placebo comparator | Participants will be provided with two bottles containing placebo. Participants will be asked to take 1 tablet of one placebo two times a day and 1 tablet of other placebo three times a day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function Scores With Intervention - HVLT and COWA
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The HVLT test assesses verbal learning and memory. Subjects are given a list of words and asked to repeat as many words as they can recall at 3 times. There is no absolute low \& high, as scores are age adjusted. Reported scores are T-scores- average score should be 50, with a standard deviation of 10. Any score below 50 indicates performance below population averages and any score above 50 indicates higher than population averages.The COWA test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with a designed letter. The scores are converted to z-scores. A Z score of -1 is 1 standard deviation below mean. The lowest and highest Z scores could be ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor fluency.
Measured: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Change in Cognitive Function Scores With Intervention - Color Trails 1 & 2
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo arms of the trial. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). Tests: Color Trails 1 \& Color Trails 2. Color Trails 1 consists of a page with scattered circles numbered from 1-25. Even numbered circles are colored yellow and odd numbered ones are colored pink. Respondents are instructed to connect the circles in consecutive numeric order with a continuous line as quickly as possible. Score is determined by recording the number of seconds required to complete the task. Color Trails 2 consists of a page containing 25 pink circles and 25 yellow circles numbered 1-60. Respondents are instructed to connect circles in consecutive order while alternating colors. A total score is determined by recording the number of seconds required to compete the task.
Measured: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Change in Cognitive Function Scores With Intervention - Digit Span
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The Digit Span assesses immediate verbal memory and auditory attention. The examiner reads increasingly longer series of numbers and the respondent is required to repeat them in the same order. The examiner then reads additional sequences of numbers and the respondent is required to repeat them in reverse order. Digit Span yields one score, number of items completed correctly. Scores are scaled from the Wechsler Adult Intelligence Scale. The values for these scaled scores indicated that values from 1-7 indicate below average performance, corresponding to 1-16 percentile ranks. Scores between 8-12 indicate average performance, corresponding to percentile ranks of 25-75. Scores between 13-19 correspond to areas of strength and 84-99 percentile ranks.
Measured: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities Test
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo arms of the trial. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The Symbol Digit Modalities Test requires respondents to write the number that corresponds with each symbol for a series of 110 items in which the symbol but not the number appears. Respondents identify the correct number using a key provided in which symbols are matched with numbers. Total score is determined by calculating the number of items correctly completed in 90 seconds Scale uses z-scores which have a mean of 0 and a standard deviation of 1. Scores cores above 0 indicate better than average performance whereas scores below 0 indicate poorer than average performance.
Measured: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Secondary outcomes (4)
Number of Participants With Adverse Events (AEs)
The primary safety endpoint is incidence and severity of AEs occurring during intervention with either COGNUTRIN or placebo. All AEs that are reported by the participant, detected during a visit, physical examination, or laboratory work-up will be recorded in the participant's medical record and recorded on the case report form (CRF). All AEs that occur after the informed consent is signed will be recorded on the AE CRF whether or not related to study agent, using the NCI Common Terminology Criteria for AEs (CTCAE) version 4.0.
Measured: 3 months from baseline +/- 7 days
Occurrence of Adverse Events (AEs) by Causality
Number of Adverse events according to relation to study treatment category: Definitely related, Probably related, Possibly related, Unlikely to be related, Unrelated.
Measured: 3 months from baseline +/- 7 days
Number of Participants Experiencing Grade 3 or Higher Adverse Events
The primary safety endpoint is incidence and severity of AEs occurring during intervention with either COGNUTRIN or placebo. All AEs that are reported by the subject, detected during a visit, physical examination, or laboratory work-up will be recorded in the participant's medical record and recorded on the case report form (CRF). All AEs that occur after the informed consent is signed will be recorded on the AE CRF whether or not related to study agent, using the NCI Common Terminology Criteria for AEs (CTCAE) version 4.0.
Measured: 3 months from baseline +/- 7 days
Number of Participants With Improvement in Function MRI and Structural MRI Post-Intervention
Functional: Improved cortical activation in multiple areas of the brain on examination of functional MRI post study intervention. Imaging including: 1) Extended resting state functional MRI with data post-processed on Philips EWS. Performed with patient's eyes closed and minds wandering. 2) Diffusion tensor imaging (DTI) with effective slice thickness of 2.3mm. Post-processed on Philips EWS with color-coded DTI tractography images obtained, absolute FA calculations performed in 9 anatomic areas in both right and left brain with total of 18 FA values obtained per examination. Structural: Improved white matter signal changes which correlate with ischemic changes or microvascular ischemic changes, cortical atrophy, hippocampal atrophy, brain volume and gray-white matter ratio. Anatomic sequences including: 1) Coronal 3-D volume T1 weighted gradient echo images with effective slice thickness of 1mm. 2) Axial FLAIR (fluid attenuated inversion recovery)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start30 Jul 2014
- Primary completion5 Apr 2017
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gateway for Cancer Research, University of South Florida
- Responsible party
- Sponsor
- Investigators
- Nagi Kumar, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823991
- Sponsor's protocol ID
- MCC-17089
- Status last verified
- Jun 2020
- First submitted
- 1 Apr 2013
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01823991
- Acronym / sponsor ID
- MCC-17089
- Conditions
- Breast Cancer
- Keywords
- polyphenolics, anthocyanins, n-3 fatty acids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Gateway for Cancer Research, University of South Florida
- Study start
- 30 Jul 2014 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 29 Aug 2019
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 this study is to examine the safety and influence of an intervention (COGNUTRIN) using nutritional supplements (n-3 fatty acids and blueberry anthocyanins) on cognitive performance in breast cancer survivors following chemotherapy. The investigators' goal is to treat or lessen the late effects of cancer treatment. The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.
Detailed description
This pilot study will evaluate the feasibility of administration of the nutritional supplement and placebo in this patient population and performing cognitive function testing at baseline and post supplementation.
This is a randomized, double-blind pilot study of COGNUTRIN vs. Placebo.
Participants have an equal chance (like flipping a coin) of being in either of the study groups. Neither the participant nor the study doctor will be able to choose which study group the participant is in. Participants will not know and the study doctor will not know which study group the participants are in.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COGNUTRIN (VITABLUE and n-3 fatty acids) | Experimental | Drug: VitaBlue™, Drug: Lovaza®Participants will be provided with two bottles containing Lovaza and VitaBlue. Participants will be asked to take 1 tablet of Lovaza two times a day and 1 tablet of VitaBlue three times a day. |
| Placebo Administration | Placebo comparator | Other: PlaceboParticipants will be provided with two bottles containing placebo. Participants will be asked to take 1 tablet of one placebo two times a day and 1 tablet of other placebo three times a day. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cases with Stage II-IIIA Breast Cancer that have completed adjuvant treatment with anthracyclines and/or taxanes + or -Radiation therapy within past 6 months(+/- 7 days) (subjects on concurrent endocrine therapy (TAM, Aromatase inhibitors are also eligible to participate as this is standard of care for this patient population)
- Able to understand and sign the informed consent
- Fluent in reading, comprehension and communication in the English language
- No evidence of dementia - Mini Mental State Examination (MMSE) >=23 but some evidence of cognitive impairment
- Must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts
Key exclusion criteria (12 listed)
- Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), androgens, Raloxifene or Tamoxifen during the previous 3 months
- Use of over the counter steroid hormonal supplements including dehydroepiandrosterone (DHEA)
- Patients with advanced or Stage IIIIB or IV breast cancer or other cancers
- Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial
- History of known allergy to components of the study supplements
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 |
|---|---|---|
| VitaBlue™Also: blueberry (BB) AnthocyaninsSelf administration of nutritional supplement COGNUTRIN for 3 months. The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza. | Drug | COGNUTRIN (VITABLUE and n-3 fatty acids) |
| PlaceboSelf administration of placebo for 3 months. Investigators use a placebo to make sure that it really is the study medicine that is making a difference in the participant's condition. It does not have anything in it that would normally help or harm most people. | Other | Placebo Administration |
| Lovaza®Also: omega-3-acid ethyl estersSelf administration of nutritional supplement COGNUTRIN for 3 months. The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza. | Drug | COGNUTRIN (VITABLUE and n-3 fatty acids) |
Primary outcome
Change in Cognitive Function Scores With Intervention - HVLT and COWA
Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The HVLT test assesses verbal learning and memory. Subjects are given a list of words and asked to repeat as many words as they can recall at 3 times. There is no absolute low \& high, as scores are age adjusted. Reported scores are T-scores- average score should be 50, with a standard deviation of 10. Any score below 50 indicates performance below population averages and any score above 50 indicates higher than population averages.The COWA test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with a designed letter. The scores are converted to z-scores. A Z score of -1 is 1 standard deviation below mean. The lowest and highest Z scores could be ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor fluency.
Change in Cognitive Function Scores With Intervention - Color Trails 1 & 2
Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo arms of the trial. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). Tests: Color Trails 1 \& Color Trails 2. Color Trails 1 consists of a page with scattered circles numbered from 1-25. Even numbered circles are colored yellow and odd numbered ones are colored pink. Respondents are instructed to connect the circles in consecutive numeric order with a continuous line as quickly as possible. Score is determined by recording the number of seconds required to complete the task. Color Trails 2 consists of a page containing 25 pink circles and 25 yellow circles numbered 1-60. Respondents are instructed to connect circles in consecutive order while alternating colors. A total score is determined by recording the number of seconds required to compete the task.
Change in Cognitive Function Scores With Intervention - Digit Span
Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The Digit Span assesses immediate verbal memory and auditory attention. The examiner reads increasingly longer series of numbers and the respondent is required to repeat them in the same order. The examiner then reads additional sequences of numbers and the respondent is required to repeat them in reverse order. Digit Span yields one score, number of items completed correctly. Scores are scaled from the Wechsler Adult Intelligence Scale. The values for these scaled scores indicated that values from 1-7 indicate below average performance, corresponding to 1-16 percentile ranks. Scores between 8-12 indicate average performance, corresponding to percentile ranks of 25-75. Scores between 13-19 correspond to areas of strength and 84-99 percentile ranks.
Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities Test
Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo arms of the trial. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The Symbol Digit Modalities Test requires respondents to write the number that corresponds with each symbol for a series of 110 items in which the symbol but not the number appears. Respondents identify the correct number using a key provided in which symbols are matched with numbers. Total score is determined by calculating the number of items correctly completed in 90 seconds Scale uses z-scores which have a mean of 0 and a standard deviation of 1. Scores cores above 0 indicate better than average performance whereas scores below 0 indicate poorer than average performance.
4 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: 3 months from baseline +/- 7 days
Occurrence of Adverse Events (AEs) by Causality
Time frame: 3 months from baseline +/- 7 days
Number of Participants Experiencing Grade 3 or Higher Adverse Events
Time frame: 3 months from baseline +/- 7 days
Number of Participants With Improvement in Function MRI and Structural MRI Post-Intervention
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nagi Kumar, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing VitaBlue™ and Lovaza® in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 8 inclusion and 12 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 Jul 2020. 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 States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Cognitive Function Scores With Intervention - HVLT and COWA (time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)). The study lists 4 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 14 Jul 2020.