Mild Cognitive Impairment (MCI)NCT07054645
Elderberry Functional Gum and Cognitive & Oral Health in Older Adults
A study testing Elderberry Anthocyanin Chewing Gum in people with Mild Cognitive Impairment (MCI) and Aging, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
Globally, the aging population is increasing rapidly, leading to a dramatic rise in the prevalence of Alzheimer's disease and other types of dementia. Neurodegenerative disorders are characterized by pathological hallmarks such as β-amyloid (Aβ) plaque accumulation, tau protein aggregation, synaptic loss, and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Aging, Oral Microbiome
- What is being tested?
- Elderberry Anthocyanin Chewing Gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Nov 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals aged 60 and over
- Individuals with mildly reduced cognitive function using the MoCA test (MoCA score: 20-25)
- Those with stable systemic diseases (e.g. HT, controlled DM)
- Those with adequate dental health (≥20 natural teeth or no chewing problems with functional prosthesis)
- Non-smokers and those who use regular medication and do not use antibiotics or antiseptic mouthwashes that could seriously affect the oral microbiota
- Individuals who are willing to participate in the study and can give written consent
Who cannot join
- Moderate to severe dementia (MoCA < 20)
- Presence of active infection or systemic inflammatory disease
- Temporomandibular joint disorders affecting gum chewing function
- Use of probiotics, prebiotics, or antibiotics within the last three months
- Known allergy to elderberry or its components
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mehmet Akif Ersoy University
Burdur
Gul Akduman, PhD., +905380458382, gakduman@mehmetakif.edu.tr
About this study
Official title: Evaluation of the Effects of Elderberry-Based Anthocyanin-Enriched Functional Chewing Gum on Cognitive Functions and Oral Microbiota in Older Adults: A Double-Blind, Randomized Controlled Trial
Globally, the aging population is increasing rapidly, leading to a dramatic rise in the prevalence of Alzheimer's disease and other types of dementia. Neurodegenerative disorders are characterized by pathological hallmarks such as β-amyloid (Aβ) plaque accumulation, tau protein aggregation, synaptic loss, and widespread neuroinflammation. These processes impair key cognitive domains including attention, memory, executive function, and orientation, hindering independent daily functioning.
Beyond cognitive decline, neurodegenerative diseases are associated with a marked deterioration in oromotor functions, such as chewing and swallowing. Mastication plays a critical role not only in digestion but also in neuro-sensory stimulation. Trigeminal nerve signaling activated by chewing enhances neurotransmitter release, boosts neurotrophic factor production (e.g., BDNF), and facilitates Aβ clearance, thereby supporting synaptic plasticity and reducing inflammation. Neuroimaging studies have shown that a higher number of functional occlusal pairs is associated with increased gray and white matter volume in regions affected early in Alzheimer's disease.
Read more
Systematic reviews have identified poor mastication and tooth loss as risk factors for cognitive decline and dementia. Mechanistically, loss of afferent input from the oral cavity-due to tooth loss, reduced chewing force, prosthetic use, or muscle atrophy-leads to reduced brain stimulation, diminished neurotrophic support, and impaired cerebral blood flow. Thus, geriatric-friendly chewing gum formulations with low elasticity and ease of chewing have been recommended.
Chewing gum is a promising vehicle for functional compounds due to its potential for transmucosal absorption and cognitive stimulation. Randomized controlled trials have shown that both active and inactive gums improve attention and reduce error rates in cognitive tasks, highlighting the beneficial effects of mastication.
Another emerging target for cognitive enhancement is the oral microbiota, a complex ecosystem of over 700 bacterial species. Dysbiosis in this ecosystem has been linked to neurological outcomes via inflammatory and neurotoxic pathways. Certain pathogens, such as Porphyromonas gingivalis, have been detected in the brains of Alzheimer's patients. Moreover, metagenomic studies have shown that reduced salivary microbial diversity correlates with poorer cognitive performance, even in young adults.
Elderberry (Sambucus nigra L.) is rich in anthocyanins (e.g., cyanidin-3-glucoside, cyanidin-3-sambubioside) with strong antioxidant and anti-inflammatory properties. Literature shows that polyphenols can be absorbed via buccal and sublingual mucosa, bypassing first-pass metabolism and providing faster systemic effects. However, the impact of anthocyanin-enriched chewing gum on oral microbiota and cognitive function has not yet been systematically investigated.
This study aims to develop and evaluate a geriatric-friendly functional chewing gum enriched with standardized elderberry anthocyanins. The intervention targets dual mechanisms-neurophysiological and microbial-to support cognitive health and balance oral microbiota in older adults.
Read the detailed description
This study is a double-blind, randomized controlled clinical trial designed to evaluate the impact of an elderberry-based functional chewing gum on cognitive function and oral microbiota in older adults.
The chewing gum intervention contains encapsulated anthocyanins derived from Sambucus nigra L., standardized for cyanidin-3-glucoside and cyanidin-3-sambubioside content, and formulated specifically for elderly individuals. The gum is designed to be soft-textured, low in elasticity, and easy to chew. It also allows transmucosal absorption through buccal and sublingual pathways, offering a rapid delivery system for polyphenols.
The study will enroll 34 participants aged 60 and above, with mild cognitive impairment (MoCA 20-25), divided equally into intervention and placebo groups. Participants will chew one gum twice daily for 6 weeks. During the intervention, participants will follow a berry-free diet to eliminate potential confounding sources of polyphenols.
Pre- and post-intervention assessments will include:
- Cognitive performance using MoCA and Stroop Color-Word Test (TBAG form)
- Salivary analysis for flow rate, pH, antioxidant capacity (FRAP), and total phenolic content (Folin-Ciocalteu)
- Microbiota profiling via 16S rRNA sequencing (in a subsample) and culturing of S. mutans and Lactobacillus spp.
- Compliance tracking via daily chewing logs and weekly monitoring
The primary hypothesis is that the anthocyanin-enriched gum will:
- Enhance cognitive performance,
- Improve oral microbial diversity,
- Reduce cariogenic bacteria (e.g., S. mutans),
- Increase salivary antioxidant capacity. Secondary goals include evaluating the gum's acceptability using a 9-point hedonic scale and assessing the stability of anthocyanin content over time.
Anthocyanin content and release will be validated by HPLC and pH-differential spectrophotometry, and stability will be tested over a 6-month period according to ICH guidelines. Statistical analysis will be performed using ANOVA, t-tests, and linear models adjusting for education and age.
This multidisciplinary study integrates dietary polyphenols, oral delivery systems, salivary biomarkers, microbiome science, and cognitive neuroscience in a novel, geriatric-focused intervention.
- Conditions
- Mild Cognitive Impairment (MCI), Aging, Oral Microbiome
- Being tested
- Elderberry Anthocyanin Chewing Gum, Placebo Chewing Gum
- Keywords
- Elderberry, Anthocyanins, Chewing Gum, Functional Food, Transmucosal Delivery, Oral Microbiota, Cognitive Function, MoCA, Aging, Mild Cognitive Impairment, Geriatric Nutrition, Randomized Controlled Trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elderberry Anthocyanin Chewing GumDietary supplement
Participants receive a functional chewing gum containing encapsulated elderberry (Sambucus nigra L.) anthocyanins standardized for cyanidin-3-glucoside and cyanidin-3-sambubioside. The gum is formulated to be geriatric-friendly (soft, low-elasticity) and is administered twice daily for 6 weeks. It enables transmucosal polyphenol delivery through buccal absorption.
Placebo Chewing GumDietary supplement
Participants receive a placebo chewing gum identical in appearance, taste, and texture to the active gum but containing no elderberry anthocyanins or bioactive compounds. The gum is administered twice daily for 6 weeks to match the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Elderberry Chewing Gum Group | Experimental | Participants receive chewing gum containing standardized elderberry anthocyanins twice daily for 6 weeks Receives: Dietary Supplement: Elderberry Anthocyanin Chewing Gum |
| Placebo Arm Title | Placebo comparator | Participants receive anthocyanin-free chewing gum matched in appearance and taste, twice daily for 6 weeks Receives: Dietary Supplement: Placebo Chewing Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function Assessed by MoCA (Montreal Cognitive Assessment) Score
The MoCA score (0-30) will be used to assess global cognitive function. A higher score indicates better cognitive performance. Measurements will be taken at baseline and at 6 weeks.
Measured: Baseline and Week 6
Secondary outcomes (10)
Change in Executive Function Assessed by Stroop Test
Cognitive flexibility and executive control will be assessed using the Stroop Color-Word Test (TBAG form). The interference score (difference in reaction time between incongruent and color conditions) will be used as the main outcome. Unit of Measure: milliseconds (ms)
Measured: Baseline and Week 6
Change in Alpha Diversity Assessed by Shannon Index
lpha diversity of oral microbiota will be assessed using the Shannon Index, based on 16S rRNA gene sequencing. Unit of Measure: Shannon diversity index (unitless)
Measured: Baseline and Week 6
Change in Beta Diversity Assessed by UniFrac and Bray-Curtis Distances
Beta diversity of oral microbiota will be assessed using UniFrac and Bray-Curtis distances, based on 16S rRNA gene sequencing. Unit of Measure: Distance metric (unitless)
Measured: Baseline and Week 6
Change in Salivary Flow Rate
Unstimulated whole saliva will be collected for 5 minutes. Flow rate will be calculated and expressed in mL/min. Differences from baseline to week 6 will be analyzed.
Measured: Baseline and Week 6
Change in Salivary pH
Salivary pH will be measured from unstimulated whole saliva samples collected over 5 minutes. Differences from baseline to week 6 will be analyzed.Unit of Measure: pH value (unitless)
Measured: Baseline and Week 6
Change in Salivary Total Antioxidant Capacity (FRAP Method)
The Ferric Reducing Antioxidant Power (FRAP) assay will be used to evaluate the total antioxidant capacity of unstimulated saliva samples. Results will be expressed as micromoles of Fe²⁺ equivalents per milliliter (µmol Fe²⁺/mL).
Measured: Baseline and Week 6
Change in Salivary Total Phenolic Content (Folin-Ciocalteu Method)
The Folin-Ciocalteu colorimetric method will be used to quantify the total phenolic content in unstimulated saliva. Results will be reported as milligrams of gallic acid equivalents per milliliter (mg GAE/mL).
Measured: Baseline and Week 6
Change in Salivary Streptococcus mutans Count
Salivary concentration of Streptococcus mutans will be assessed using microbiological culturing on selective agar. Results will be reported as colony-forming units per milliliter (CFU/mL).
Measured: Baseline and Week 6
Change in Salivary Lactobacillus spp. Count
Salivary concentration of Lactobacillus spp. will be assessed using microbiological culturing on selective agar. Results will be reported as colony-forming units per milliliter (CFU/mL).
Measured: Baseline and Week 6
Product Acceptability Score (Hedonic Scale)
Participants will evaluate the taste, texture, aroma, and overall liking of the chewing gum using a 9-point hedonic scale (1 = Dislike extremely, 9 = Like extremely). Higher scores indicate greater acceptability.
Unit of Measure: Score (1-9)
Measured: Initial Exposure and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group design. Participants are randomly assigned to either the intervention group (elderberry-based anthocyanin chewing gum) or the placebo group. Both groups are assessed at baseline and after 6 weeks of intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Akduman, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054645
- Sponsor's protocol ID
- MAKU-AKDUMAN-1002-2025
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy concerns. The study protocol did not include participant consent for open data sharing, and the dataset contains potentially identifiable health information.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Elderberry-Based Anthocyanin-Enriched Functional Chewing Gum on Cognitive Functions and Oral Microbiota in Older Adults: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07054645
- Acronym / sponsor ID
- MAKU-AKDUMAN-1002-2025
- Conditions
- Mild Cognitive Impairment (MCI), Aging, Oral Microbiome
- Keywords
- Elderberry, Anthocyanins, Chewing Gum, Functional Food, Transmucosal Delivery, Oral Microbiota, Cognitive Function, MoCA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 Jul 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.
Globally, the aging population is increasing rapidly, leading to a dramatic rise in the prevalence of Alzheimer's disease and other types of dementia. Neurodegenerative disorders are characterized by pathological hallmarks such as β-amyloid (Aβ) plaque accumulation, tau protein aggregation, synaptic loss, and widespread neuroinflammation. These processes impair key cognitive domains including attention, memory, executive function, and orientation, hindering independent daily functioning.
Beyond cognitive decline, neurodegenerative diseases are associated with a marked deterioration in oromotor functions, such as chewing and swallowing. Mastication plays a critical role not only in digestion but also in neuro-sensory stimulation. Trigeminal nerve signaling activated by chewing enhances neurotransmitter release, boosts neurotrophic factor production (e.g., BDNF), and facilitates Aβ clearance, thereby supporting synaptic plasticity and reducing inflammation. Neuroimaging studies have shown that a higher number of functional occlusal pairs is associated with increased gray and white matter volume in regions affected early in Alzheimer's disease.
Systematic reviews have identified poor mastication and tooth loss as risk factors for cognitive decline and dementia. Mechanistically, loss of afferent input from the oral cavity-due to tooth loss, reduced chewing force, prosthetic use, or muscle atrophy-leads to reduced brain stimulation, diminished neurotrophic support, and impaired cerebral blood flow. Thus, geriatric-friendly chewing gum formulations with low elasticity and ease of chewing have been recommended.
Chewing gum is a promising vehicle for functional compounds due to its potential for transmucosal absorption and cognitive stimulation. Randomized controlled trials have shown that both active and inactive gums improve attention and reduce error rates in cognitive tasks, highlighting the beneficial effects of mastication.
Another emerging target for cognitive enhancement is the oral microbiota, a complex ecosystem of over 700 bacterial species. Dysbiosis in this ecosystem has been linked to neurological outcomes via inflammatory and neurotoxic pathways. Certain pathogens, such as Porphyromonas gingivalis, have been detected in the brains of Alzheimer's patients. Moreover, metagenomic studies have shown that reduced salivary microbial diversity correlates with poorer cognitive performance, even in young adults.
Elderberry (Sambucus nigra L.) is rich in anthocyanins (e.g., cyanidin-3-glucoside, cyanidin-3-sambubioside) with strong antioxidant and anti-inflammatory properties. Literature shows that polyphenols can be absorbed via buccal and sublingual mucosa, bypassing first-pass metabolism and providing faster systemic effects. However, the impact of anthocyanin-enriched chewing gum on oral microbiota and cognitive function has not yet been systematically investigated.
This study aims to develop and evaluate a geriatric-friendly functional chewing gum enriched with standardized elderberry anthocyanins. The intervention targets dual mechanisms-neurophysiological and microbial-to support cognitive health and balance oral microbiota in older adults.
Detailed description
This study is a double-blind, randomized controlled clinical trial designed to evaluate the impact of an elderberry-based functional chewing gum on cognitive function and oral microbiota in older adults.
The chewing gum intervention contains encapsulated anthocyanins derived from Sambucus nigra L., standardized for cyanidin-3-glucoside and cyanidin-3-sambubioside content, and formulated specifically for elderly individuals. The gum is designed to be soft-textured, low in elasticity, and easy to chew. It also allows transmucosal absorption through buccal and sublingual pathways, offering a rapid delivery system for polyphenols.
The study will enroll 34 participants aged 60 and above, with mild cognitive impairment (MoCA 20-25), divided equally into intervention and placebo groups. Participants will chew one gum twice daily for 6 weeks. During the intervention, participants will follow a berry-free diet to eliminate potential confounding sources of polyphenols.
Pre- and post-intervention assessments will include:
- Cognitive performance using MoCA and Stroop Color-Word Test (TBAG form)
- Salivary analysis for flow rate, pH, antioxidant capacity (FRAP), and total phenolic content (Folin-Ciocalteu)
- Microbiota profiling via 16S rRNA sequencing (in a subsample) and culturing of S. mutans and Lactobacillus spp.
- Compliance tracking via daily chewing logs and weekly monitoring
The primary hypothesis is that the anthocyanin-enriched gum will:
- Enhance cognitive performance,
- Improve oral microbial diversity,
- Reduce cariogenic bacteria (e.g., S. mutans),
- Increase salivary antioxidant capacity. Secondary goals include evaluating the gum's acceptability using a 9-point hedonic scale and assessing the stability of anthocyanin content over time.
Anthocyanin content and release will be validated by HPLC and pH-differential spectrophotometry, and stability will be tested over a 6-month period according to ICH guidelines. Statistical analysis will be performed using ANOVA, t-tests, and linear models adjusting for education and age.
This multidisciplinary study integrates dietary polyphenols, oral delivery systems, salivary biomarkers, microbiome science, and cognitive neuroscience in a novel, geriatric-focused intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group design. Participants are randomly assigned to either the intervention group (elderberry-based anthocyanin chewing gum) or the placebo group. Both groups are assessed at baseline and after 6 weeks of intervention.
| Arm | Type | Receives |
|---|---|---|
| Elderberry Chewing Gum Group | Experimental | Dietary Supplement: Elderberry Anthocyanin Chewing GumParticipants receive chewing gum containing standardized elderberry anthocyanins twice daily for 6 weeks |
| Placebo Arm Title | Placebo comparator | Dietary Supplement: Placebo Chewing GumParticipants receive anthocyanin-free chewing gum matched in appearance and taste, twice daily for 6 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Individuals aged 60 and over
- Individuals with mildly reduced cognitive function using the MoCA test (MoCA score: 20-25)
- Those with stable systemic diseases (e.g. HT, controlled DM)
- Those with adequate dental health (≥20 natural teeth or no chewing problems with functional prosthesis)
- Non-smokers and those who use regular medication and do not use antibiotics or antiseptic mouthwashes that could seriously affect the oral microbiota
Key exclusion criteria (5 listed)
- Moderate to severe dementia (MoCA < 20)
- Presence of active infection or systemic inflammatory disease
- Temporomandibular joint disorders affecting gum chewing function
- Use of probiotics, prebiotics, or antibiotics within the last three months
- Known allergy to elderberry or its components
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 |
|---|---|---|
| Elderberry Anthocyanin Chewing GumParticipants receive a functional chewing gum containing encapsulated elderberry (Sambucus nigra L.) anthocyanins standardized for cyanidin-3-glucoside and cyanidin-3-sambubioside. The gum is formulated to be geriatric-friendly (soft, low-elasticity) and is administered twice daily for 6 weeks. It enables transmucosal polyphenol delivery through buccal absorption. | Dietary supplement | Elderberry Chewing Gum Group |
| Placebo Chewing GumParticipants receive a placebo chewing gum identical in appearance, taste, and texture to the active gum but containing no elderberry anthocyanins or bioactive compounds. The gum is administered twice daily for 6 weeks to match the intervention group. | Dietary supplement | Placebo Arm Title |
Primary outcome
Change in Cognitive Function Assessed by MoCA (Montreal Cognitive Assessment) Score
Time frame: Baseline and Week 6
The MoCA score (0-30) will be used to assess global cognitive function. A higher score indicates better cognitive performance. Measurements will be taken at baseline and at 6 weeks.
10 secondary outcomes
Change in Executive Function Assessed by Stroop Test
Time frame: Baseline and Week 6
Change in Alpha Diversity Assessed by Shannon Index
Time frame: Baseline and Week 6
Change in Beta Diversity Assessed by UniFrac and Bray-Curtis Distances
Time frame: Baseline and Week 6
Change in Salivary Flow Rate
Time frame: Baseline and Week 6
Change in Salivary pH
Time frame: Baseline and Week 6
Change in Salivary Total Antioxidant Capacity (FRAP Method)
Time frame: Baseline and Week 6
Change in Salivary Total Phenolic Content (Folin-Ciocalteu Method)
Time frame: Baseline and Week 6
Change in Salivary Streptococcus mutans Count
Time frame: Baseline and Week 6
Change in Salivary Lactobacillus spp. Count
Time frame: Baseline and Week 6
Product Acceptability Score (Hedonic Scale)
Time frame: Initial Exposure and Week 6
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 8 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy concerns. The study protocol did not include participant consent for open data sharing, and the dataset contains potentially identifiable health information.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elderberry Anthocyanin Chewing Gum in people with Mild Cognitive Impairment (MCI) and Aging, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
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 6 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: opening soon, as of the sponsor's last update on 8 Jul 2025. 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 Turkey (Türkiye). 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?
Contact Gül Akduman, PhD. (+905380458382, gakduman@mehmetakif.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Assessed by MoCA (Montreal Cognitive Assessment) Score (time frame: Baseline and Week 6). 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 8 Jul 2025.