PerimenopauseNCT07242430
12-week Multi-vitamin/Mineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being.
A study testing Multivitamin/mineral supplement in people with Perimenopause and Perimenopausal Women, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Perimenopause is a stage of transition into menopause that is marked by menopausal symptoms while menstruation is still taking place. Perimenopause symptoms include mood changes, anxiety, sleep disruptions, hot flushes, night sweats, fatigue, and cognitive challenges. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Perimenopausal Women, Perimenopause, Climacteric Syndrome
- What is being tested?
- Multivitamin/mineral supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2026to 8 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-assess as healthy
- Report experiencing troublesome peri-menopause symptoms in the past 6 months but not post-menopausal (defined as 12 months with no periods)
Who cannot join
- Post-menopausal
- Lactating, pregnant or seeking to become pregnant
- Nut Allergy
- Taken antidepressant/antianxiety medication or other medication with strong likelihood for effects on cognition or sleep in the past 6 months.
- Habitual multi-vitamin/mineral supplementation (defined as more than 3 consecutive days or 4 days in total). Will be excluded unless washout for 1 month.
- Menopause symptoms have been medically induced.
- Receiving gender-affirming hormone therapy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Psychology, Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: Effects of 12-week Multi-vitamin/Mineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial
Perimenopause is a stage of transition into menopause that is marked by menopausal symptoms while menstruation is still taking place. Perimenopause symptoms include mood changes, anxiety, sleep disruptions, hot flushes, night sweats, fatigue, and cognitive challenges. The frequency and severity of these symptoms can seriously impair women's quality of life. Even if the public's awareness on menopause has increased, there are still a lot of unanswered questions. A connection between nutrition and menopause management has been proposed in earlier research. However, there is limited research in this field, and women frequently turn to social media for supplement recommendations in order to deal with menopause-related issues.
Vitamins and minerals such as vitamin D and calcium are recommended by the European Menopause and Andropause Society and there is limited evidence to suggests that soy and herbals may have a beneficial effect on menopausal symptoms, but more research is needed.
The aim of this study is to investigate the effects of 12-weeks multi-vitamin/mineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being.
Read the detailed description
Perimenopause is the stage of a woman's life when she has not yet gone a full year without her period but is still undergoing changes due to changing hormones. It often occurs in our 40s, but some women may experience it sooner. It is a normal aspect of aging. While each person experiences symptoms differently, some common ones include irregular periods, hot flushes, night sweats, mood swings, difficulty sleeping, decreased libido, vaginal dryness, memory and concentration problems, joint and muscle aches, fatigue, headaches, and changes in skin or hair.
Hormone replacement therapy (HRT), which is available through general practitioners and comes in a variety of forms, is currently the first line of treatment for menopause symptoms. However, some people might decide against using HRT because of adverse effects or because it's inappropriate for them for other reasons.
Supplement companies are starting to market to women who are increasingly using social media to seek advice on how to manage their symptoms by making claims that their products can lessen menopausal symptoms.
Although there is evidence linking nutrition to menopause, there are limited research on the subject, especially when it comes to perimenopause. The European Menopause and Andropause Society recommends vitamins and minerals including calcium and vitamin D. There is also some evidence that soy and herbal remedies like sage, green tea, and ashwaganda may help with menopausal symptoms, but more research is required.
The aim of this study is to investigate the effects of a multi-vitamin/mineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being when taken for 3 months. These effects will be compared to the effects of an inert placebo taken over the same time frame.
- Being tested
- Placebo, Multivitamin/mineral supplement
- Keywords
- perimenopause, cognition, psychological wellbeing, sleep, magnesium, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
12 week placebo supplement of 1 tablet per day
Multivitamin/mineral supplementDietary supplement
12 week supplementation of 1 tablet per day of multivitamin/mineral supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsule consumed for 84 days Receives: Other: Placebo |
| Multivitamin/mineral (1 Tablet) | Experimental | Multivitamin/mineral supplement consumed for 84 days Receives: Dietary Supplement: Multivitamin/mineral supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric working memory % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Numeric working memory reaction time
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
3-back % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
3-Back reaction time
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Corsi blocks task score
Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Alphabetic working memory task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Alphabetic working memory reaction time
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Word recognition % accuracy
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Word recognition reaction time
Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Picture recognition % accuracy
Cognitive function - episodic memory task. Measured as a percentage, with a higher score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Picture recognition reaction time
Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Secondary outcomes (7)
The Menopause-Specific Quality of Life Questionnaire (Hilditch, 1996)
Assesses the effect of menopausal symptoms on quality of life in four domains: vasomotor, psychosocial, physical, and sexual; as well as providing a total score. The questionnaire has 29 items, each item is a symptom of menopause, the participants rate each symptom between 0 (not at all bothered) to 6 (bothered all the time.) The vasomotor symptoms include items such as 'hot flushes' and 'sweating'; psychological symptoms include 'accomplishing less than I used to' and 'poor memory'; physical symptoms include 'difficulty sleeping' and 'weight gain'; sexual symptoms include 'vaginal dryness' and 'avoiding intimacy'. A conversion score is created for each of the 4 domains: vasomotor; psychosocial; physical; sexual; as well as a total score. Each score ranges from 1 -8, with higher scores indicating greater problems.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Centre for Epidemiologic Studies Depression Scale (Radlof, 1997)
This is an established questionnaire used to measure symptoms associated with depression. The questionnaire has 20 items, including 'my sleep is restless', 'I felt depressed' and 'I felt lonely'. The participants rate the symptom on a scale between <1 day and 5 to 7 days, the 4 scale points are: Rarely or none of the time (less than 1 day); Some or a little of the time (1-2 days); Occasionally or a moderate amount of time (3-4 days); Most or all of the time (5-7 days). The possible range of scores is between 0 to 60, higher scores indicate more presence of symptomatology. The scoring of positive items is reversed.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
The State-Trait Anxiety Inventory, TRAIT subscale (Spielberger, 1983)
The state-trait anxiety inventory will be used to measure anxiety levels, specifically trait anxiety. It consists of 20 items and the scale ranges from 1 to 4: 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always. The nine positive items will be reversed for scoring, items 21, 23, 26, 27, 30, 33, 34, 36 and 39. The possible range of scores is 20 to 80, higher scores indicate higher levels of trait anxiety within the participant. Examples of items within the questionnaire include: 'I feel like a failure' and 'I feel secure'.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
The Perceived Stress Scale (Cohen et al., 1983)
This established questionnaire will be used to measure the perception of stress. Each of the ten items are rated on a scale between 0 (never) to 4 (very often.) The five scale points are 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often. The four positive items will be reversed for scoring, items 4, 5, 7 and 8. The questionnaire item examples include 'In the last month, how often have you been upset because of something that happened unexpectedly?' and 'In the last month, how often have you felt that you were unable to control the important things in your life?'. The possible range of scores is between 0 to 40, higher scores indicate high participant perceived stress.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Visual Analogue Mood Scales (VAMS)
This is a series of mood scales. Each scale is a line anchored at either side by an adjective describing a mood. Participants must click at a point on the scale that represents how they are feeling at that point in time. There are 18 scales in total, each scored out of 100. From these scales three composite scores are calculated describing feelings of 'Alertness', 'Stress' and 'Tranquillity', which are also presented as a score out of 100.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Sleep Related Impairment (PROMIS-SRI) (Yu et al., 2011)
The PROMIS-SRI will be used to measure sleep related impairment. The questionnaire contains 8 items, and participants are required to answer in relation to their sleep within the past 7 days. Each item is rated on a scale from 1-5. The items are then summed to create a single value (range 8-40), with higher scores indicating higher levels of sleep disturbance. Examples of items within the questionnaire include: 'I felt alert when I woke up' and 'I had a hard time getting things done because I was sleepy'.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Sleep Disturbance (PROMIS-SD) (Yu et al., 2011)
The PROMIS-SD will be used to measure sleep disturbance. The questionnaire contains 8 items, and participants are required to answer in relation to their sleep within the past 7 days. Each item is rated on a scale from 1-5. The items are then summed to create a single value (range 8-40), with higher scores indicating higher levels of sleep disturbance. Examples of items within the questionnaire include: 'my sleep was restless' and 'I had difficulty falling asleep'.
Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start7 Apr 2026
- Primary completion25 Oct 2026 (estimated)
- Study completion8 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active vs. placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Vitabiotics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242430
- Sponsor's protocol ID
- 10806
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised dataset will be shared on this platform within the results section. Any information which may identify individual participants will be removed from the dataset before it is shared. Data will be shared in accordance with FAIR (findable, accessible, interoperable, reusable) principles. Participants will consent to the data being shared in this way.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12-week Multi-vitamin/Mineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07242430
- Acronym / sponsor ID
- 10806
- Keywords
- perimenopause, cognition, psychological wellbeing, sleep, magnesium, memory
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Vitabiotics
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 8 Dec 2026 (estimated)
- First posted
- 21 Nov 2025 (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.
Perimenopause is a stage of transition into menopause that is marked by menopausal symptoms while menstruation is still taking place. Perimenopause symptoms include mood changes, anxiety, sleep disruptions, hot flushes, night sweats, fatigue, and cognitive challenges. The frequency and severity of these symptoms can seriously impair women's quality of life. Even if the public's awareness on menopause has increased, there are still a lot of unanswered questions. A connection between nutrition and menopause management has been proposed in earlier research. However, there is limited research in this field, and women frequently turn to social media for supplement recommendations in order to deal with menopause-related issues.
Vitamins and minerals such as vitamin D and calcium are recommended by the European Menopause and Andropause Society and there is limited evidence to suggests that soy and herbals may have a beneficial effect on menopausal symptoms, but more research is needed.
The aim of this study is to investigate the effects of 12-weeks multi-vitamin/mineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being.
Detailed description
Perimenopause is the stage of a woman's life when she has not yet gone a full year without her period but is still undergoing changes due to changing hormones. It often occurs in our 40s, but some women may experience it sooner. It is a normal aspect of aging. While each person experiences symptoms differently, some common ones include irregular periods, hot flushes, night sweats, mood swings, difficulty sleeping, decreased libido, vaginal dryness, memory and concentration problems, joint and muscle aches, fatigue, headaches, and changes in skin or hair.
Hormone replacement therapy (HRT), which is available through general practitioners and comes in a variety of forms, is currently the first line of treatment for menopause symptoms. However, some people might decide against using HRT because of adverse effects or because it's inappropriate for them for other reasons.
Supplement companies are starting to market to women who are increasingly using social media to seek advice on how to manage their symptoms by making claims that their products can lessen menopausal symptoms.
Although there is evidence linking nutrition to menopause, there are limited research on the subject, especially when it comes to perimenopause. The European Menopause and Andropause Society recommends vitamins and minerals including calcium and vitamin D. There is also some evidence that soy and herbal remedies like sage, green tea, and ashwaganda may help with menopausal symptoms, but more research is required.
The aim of this study is to investigate the effects of a multi-vitamin/mineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being when taken for 3 months. These effects will be compared to the effects of an inert placebo taken over the same time frame.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active vs. placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsule consumed for 84 days |
| Multivitamin/mineral (1 Tablet) | Experimental | Dietary Supplement: Multivitamin/mineral supplementMultivitamin/mineral supplement consumed for 84 days |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Self-assess as healthy
- Report experiencing troublesome peri-menopause symptoms in the past 6 months but not post-menopausal (defined as 12 months with no periods)
Key exclusion criteria (7 listed)
- Post-menopausal
- Lactating, pregnant or seeking to become pregnant
- Nut Allergy
- Taken antidepressant/antianxiety medication or other medication with strong likelihood for effects on cognition or sleep in the past 6 months.
- Habitual multi-vitamin/mineral supplementation (defined as more than 3 consecutive days or 4 days in total). Will be excluded unless washout for 1 month.
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 |
|---|---|---|
| Placebo12 week placebo supplement of 1 tablet per day | Other | Placebo |
| Multivitamin/mineral supplement12 week supplementation of 1 tablet per day of multivitamin/mineral supplement | Dietary supplement | Multivitamin/mineral (1 Tablet) |
Primary outcome
Numeric working memory % accuracy
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Numeric working memory reaction time
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
3-back % accuracy
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
3-Back reaction time
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Corsi blocks task score
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance.
Alphabetic working memory task % accuracy
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Alphabetic working memory reaction time
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Word recognition % accuracy
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance.
Word recognition reaction time
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Picture recognition % accuracy
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - episodic memory task. Measured as a percentage, with a higher score indicating better performance.
Picture recognition reaction time
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
7 secondary outcomes
The Menopause-Specific Quality of Life Questionnaire (Hilditch, 1996)
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Centre for Epidemiologic Studies Depression Scale (Radlof, 1997)
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
The State-Trait Anxiety Inventory, TRAIT subscale (Spielberger, 1983)
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
The Perceived Stress Scale (Cohen et al., 1983)
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Visual Analogue Mood Scales (VAMS)
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Sleep Related Impairment (PROMIS-SRI) (Yu et al., 2011)
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Sleep Disturbance (PROMIS-SD) (Yu et al., 2011)
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. An anonymised dataset will be shared on this platform within the results section. Any information which may identify individual participants will be removed from the dataset before it is shared. Data will be shared in accordance with FAIR (findable, accessible, interoperable, reusable) principles. Participants will consent to the data being shared in this way.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamin/mineral supplement in people with Perimenopause and Perimenopausal Women, run by Northumbria University 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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Numeric working memory % accuracy (time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.). The study lists 11 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 5 Aug 2026.