Cognitive DeclineNCT06523218
A Clinical Trial to Investigate the Efficacy of a Supplement to Improve and Maintain Cognitive Function and Memory
A study testing MindMD Supplement in people with Cognitive Decline and Cognitive Function, run by Scale Media Inc at 1 site in United States.
Trial summary
This study will evaluate the efficacy of 1MD Nutrition's MindMD supplement in improving and maintaining cognitive function and memory. The randomized controlled trial will include 50 healthy participants aged 50-75 years, lasting for 3 months. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Function
- What is being tested?
- MindMD Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 17 Aug 2024
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-75 years
- Regular experience of symptoms related to cognitive decline (e.g., forgetfulness, lack of focus, brain fog)
- Generally healthy without uncontrolled chronic diseases
- Willingness to avoid certain medications and supplements during the study
Who cannot join
- Any medical condition or treatment impacting cognitive ability Mental health or neurological disorders
- Severe allergies, particularly to soy or other product ingredients
- Taking blood thinning medication
- Recent or planned surgeries
- Major illness in the past three months
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the efficacy of 1MD Nutrition's MindMD supplement in improving and maintaining cognitive function and memory. The randomized controlled trial will include 50 healthy participants aged 50-75 years, lasting for 3 months. Participants will be randomized to receive either the test product or a placebo.
- Conditions
- Cognitive Decline, Cognitive Function
- Being tested
- MindMD Supplement, Placebo
- Keywords
- Cognitive Health, Healthy Aging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindMD SupplementDietary supplement
Participants will take two capsules of the MindMD supplement once daily with their morning meal for a duration of 3 months. The supplement is designed to improve and maintain cognitive function and memory.
PlaceboOther
Participants will take two capsules of the placebo once daily with their morning meal for a duration of 3 months. The placebo is designed to be indistinguishable in appearance and administration from the MindMD supplement to ensure blinding.
| Study group | Role | What they receive |
|---|---|---|
| MindMD Supplement | Experimental | Participants in the experimental group will receive the MindMD supplement, which contains the following ingredients: 600 mg Bacopa monnieri (Bacognize®), 250 mg Cognigrape® Grape Extract, 100 mg Phosphatidylserine, 50 mg Green Tea Leaf Extract, 1.7 mg Vitamin B6, and 200 mcg Folate (120 mcg folic acid). Receives: Dietary Supplement: MindMD Supplement |
| Placebo | Placebo comparator | Participants in the placebo group will receive a placebo, which contains rice flour encapsulated in a vegetable cellulose capsule. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function and Memory Improvement
Measurement of cognitive function and memory through Cognitive Battery Testing. The Cognitive Battery Testing includes assessments such as Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, and Spatial Planning. These assessments provide objective measurements of various cognitive functions, including processing speed, memory recall, selective attention, and executive function.
Measured: Baseline, Month 2, and Month 3
Secondary outcomes (3)
Participants' Perceptions of Cognitive Function and Memory using the Cognitive Function Questionnaire
Evaluation of participants' self-reported perceptions of the effect of the MindMD supplement on cognitive function and memory. This includes aspects such as focus and attentiveness, comprehension and mental clarity, learning acuity, absentmindedness, and overall quality of life. These perceptions will be measured through the Cognitive Function Questionnaire (CFQ) at specified time points: Baseline (Day 0), Month 1, Month 2, and Month 3.
Measured: Baseline, Month 1, Month 2, and Month 3
Participants' Quality of Life
Assessment of participants' quality of life using the WHO-5 Well-Being Index. These assessments will be conducted at Baseline (Day 0), Month 1, Month 2, and Month 3.
Measured: Baseline, Month 1, Month 2, and Month 3
Participants' Focus and Attentiveness
Evaluation of participants' focus and attentiveness using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 0), Month 1, Month 2, and Month 3.
Measured: Baseline, Month 1, Month 2, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start17 May 2024
- Primary completion17 Aug 2024 (estimated)
- Study completion17 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scale Media Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523218
- Sponsor's protocol ID
- 20429
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 26 Jul 2024
- 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 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Investigate the Efficacy of a Supplement to Improve and Maintain Cognitive Function and Memory
- ClinicalTrials.gov ID
- NCT06523218
- Acronym / sponsor ID
- 20429
- Conditions
- Cognitive Decline, Cognitive Function
- Keywords
- Cognitive Health, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Scale Media IncIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 17 May 2024 (actual)
- Primary completion
- 17 Aug 2024 (estimated)
- Study completion
- 17 Aug 2024 (estimated)
- First posted
- 26 Jul 2024 (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.
This study will evaluate the efficacy of 1MD Nutrition's MindMD supplement in improving and maintaining cognitive function and memory. The randomized controlled trial will include 50 healthy participants aged 50-75 years, lasting for 3 months. Participants will be randomized to receive either the test product or a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MindMD Supplement | Experimental | Dietary Supplement: MindMD SupplementParticipants in the experimental group will receive the MindMD supplement, which contains the following ingredients: 600 mg Bacopa monnieri (Bacognize®), 250 mg Cognigrape® Grape Extract, 100 mg Phosphatidylserine, 50 mg Green Tea Leaf Extract, 1.7 mg Vitamin B6, and 200 mcg Folate (120 mcg folic acid). |
| Placebo | Placebo comparator | Other: PlaceboParticipants in the placebo group will receive a placebo, which contains rice flour encapsulated in a vegetable cellulose capsule. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50-75 years
- Regular experience of symptoms related to cognitive decline (e.g., forgetfulness, lack of focus, brain fog)
- Generally healthy without uncontrolled chronic diseases
- Willingness to avoid certain medications and supplements during the study
Key exclusion criteria (5 listed)
- Any medical condition or treatment impacting cognitive ability Mental health or neurological disorders
- Severe allergies, particularly to soy or other product ingredients
- Taking blood thinning medication
- Recent or planned surgeries
- Major illness in the past three months
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 |
|---|---|---|
| MindMD SupplementParticipants will take two capsules of the MindMD supplement once daily with their morning meal for a duration of 3 months. The supplement is designed to improve and maintain cognitive function and memory. | Dietary supplement | MindMD Supplement |
| PlaceboParticipants will take two capsules of the placebo once daily with their morning meal for a duration of 3 months. The placebo is designed to be indistinguishable in appearance and administration from the MindMD supplement to ensure blinding. | Other | Placebo |
Primary outcome
Cognitive Function and Memory Improvement
Time frame: Baseline, Month 2, and Month 3
Measurement of cognitive function and memory through Cognitive Battery Testing. The Cognitive Battery Testing includes assessments such as Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, and Spatial Planning. These assessments provide objective measurements of various cognitive functions, including processing speed, memory recall, selective attention, and executive function.
3 secondary outcomes
Participants' Perceptions of Cognitive Function and Memory using the Cognitive Function Questionnaire
Time frame: Baseline, Month 1, Month 2, and Month 3
Participants' Quality of Life
Time frame: Baseline, Month 1, Month 2, and Month 3
Participants' Focus and Attentiveness
Time frame: Baseline, Month 1, Month 2, and Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 MindMD Supplement in people with Cognitive Decline and Cognitive Function, run by Scale Media Inc 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jul 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Cognitive Function and Memory Improvement (time frame: Baseline, Month 2, and Month 3). 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 26 Jul 2024.