Alzheimer's DiseaseNCT03269149
Tango for Alzheimer's Disease Patients' Caregivers
A study testing Adapted Tango Dance and Educational lectures in people with Alzheimer's Disease, run by Emory University at 1 site in United States.
Trial summary
The goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in African American (AA) female family caregivers, at high risk for Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Adapted Tango Dance and Educational lectures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2017to 31 Dec 2018
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women family caregivers from the Emory ADRC and Dr. Wharton's studies of Alzheimer's disease (AD) caregivers
- Parental diagnosis 'probable AD'
- African-American
- 45-65 years of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical Center, Emory University, Executive Park, Wesley Woods
Atlanta, Georgia, 30322
About this study
Official title: Effects of Adapted Tango on African-American Women Caregivers of Alzheimer's Disease Patients
The goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in African American (AA) female family caregivers, at high risk for Alzheimer's disease (AD).
Read the detailed description
The importance of informal family caregiving in Alzheimer's disease (AD) is well-established. African-American caregivers are most often middle aged adult children of AD patients (vs. spouses), women, and are at higher risk for chronic health problems. AD lifestyle interventions offer an alternative to medication, and are generally affordable, accessible, and adaptable to the lives of caregivers. To date, most non-pharmaceutical interventions have focused on exercise and nutrition, both of which have proven to be highly successful in conferring AD related benefits and decreasing AD risk.
The goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in African American (AA) female family caregivers, at high risk for Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- Adapted Tango Dance, Educational lectures
- Keywords
- Alzheimer's disease, African-American Women, Caregivers, Tango, Dance-based intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Tango DanceOther
20 improvisational, 90-minute adapted tango dance sessions over a 12-week period. Classes begin with a 20-minute standing warm-up followed by partnering and rhythmic exercises. Next, novel step elements are introduced and participants will be taught how to combine the new steps with previously learned steps via improvisation. Caregivers will dance with each other or undergraduate /graduate student volunteers. Music will be played throughout classes and artistic expression, i.e., attention to aesthetics, and improvisation, will be encouraged.
Educational lecturesBehavioural
Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks. Classes will also be 1.5 hours long and will involve lecture, partnered and group learning and extensive Q\&A will be encouraged.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Tango Dance | Experimental | 20 improvisational, 90-minute adapted tango dance sessions over a 12-week period. Receives: Other: Adapted Tango Dance |
| Educational Control | Active comparator | Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks. Receives: Behavioral: Educational lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in interleukin-7
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in interleukin-8
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in interleukin-9
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in Interleukin-10
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in interferon induced protein 10
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in macrophage derived chemokine
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in monocyte chemoattractant protein 1
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in transforming growth factor alpha
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in tumor necrosis factor alpha
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in C-reactive protein
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Change in serum amyloid protein
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Measured: Before and after the intervention / control at least 20 times during 12 weeks
Secondary outcomes (17)
Change in Montreal Cognitive Assessment (MoCA)
The MoCA test is a 30-point test that assesses several cognitive domains. The short-term memory recall task (5 points) ; Visuospatial abilities are assessed using a clock-drawing task (3 points) and a three-dimensional cube copy (1 point); executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration and working memory are evaluated using a attention task (target detection using tapping; 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each). Language is assessed using a confrontation naming task with low-familiarity animals (3 points), repetition of two syntactically complex sentences (2 points), and the aforementioned fluency task. Finally, orientation to time and place is evaluated (6 points).
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Tower of London test
The Tower of London test is used for the assessment of executive functioning specifically to detect deficits in planning. It is related to the classic problem-solving puzzle known as the Tower of Hanoi.The test consists of two boards with pegs and several beads with different colors. The examiner uses the beads and the boards to present the examinee with problem-solving tasks. The performance of the examinee is compared to representative samples of individuals of the same age to derive hypotheses about the person's executive cognitive ability.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Stroop interference test
The Stroop test is to name the color in which a word is printed, ignoring the word itself. The Stroop Test is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the imultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Total time needed for each card is the outcome variable.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Trails B test
Trail Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test is used as the primary performance metric.The test is sensitive to detecting cognitive impairment.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Digit Span test
The Digit Span test is either conducted verbally or using a computer program. A sequence of numbers is shown or read out to the participant. The participant is then told to repeat the numbers that were shown or read to them. This process continues until the participant can no longer remember either the full sequence of numbers or the correct order.The Digit Span test is scored by the amount of numbers the participant was able to remember in each test. The scorer must add the total number of correct sequences, backwards and forwards.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Buschke Selective Reminding Test
The Buschke Selective Reminding Test (SRT) is a test designed to measure verbal learning and memory through the use of a list-learning procedure over multiple trials. The adult SRT involves reading the subject a list of 12 unrelated words and then having the subject immediately recall as many of these 12 words as possible. Every trial after the first involves selectively presenting only those words in which the subject did not recall on the immediately preceding trial. The selective reminding trials proceed in this manner until the subject is able to correctly recall all 12 words on three consecutive trials, or until 12 trials have been completed. Scoring of the test has been automated according the instructions of Buschke.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Reverse Corsi Blocks test
The Corsi block-tapping test is a psychological test that assesses visuo-spatial short term working memory. It involves mimicking a researcher as he/she taps a sequence of up to nine identical spatially separated blocks. The sequence starts out simple, usually using two blocks, but becomes more complex until the subject's performance suffers. This number is known as the Corsi Span, and averages about 5 for normal human subjects.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Brooks spatial memory test
Brooks spatial memory task (BSMT): In the BSMT, the participant visualizes a 4x4 matrix in which the location of numbers 1 through 8 is described. Participants practice with 3 instructions and progress up to 8 instructions. All levels are completed regardless of errors. Percentages correct (out of 50) will be used for analysis.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Body position spatial task (BPST)
Body position spatial task (BPST) measures whole body knowledge of spatial position and ability to navigate in a remembered path. The examiner verbally and visually demonstrates combinations of 5 possible moves: step forward, step left, step right, quarter turn left, and quarter turn right. The examiner begins with 2 moves and progresses up to 9 moves, with 2 trials per level. Participants continue to the next level if one trial is correctly performed. The test ends when participants miss both trials of a level. Span length and number of correct trials are variables.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Fullerton Advanced Balance Scale
The Fullerton Test is mainly intended to identify highly-active older adults who are at an increased risk to experience fall-related injuries due to sensory impairments. The test uses both dynamic and static balance under different situations to identify balance deficits in older adults. The test includes the following: 10 performance based activities in both static and dynamic phases; Score of 0-40/40 points possible (higher scores are better); tems scored on a 5 point ordinal scale (0-4).
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in 30-second chair stand
The 30 second chair test is administered using a folding chair without arms, with seat height of 17 inches (43.2 cm). The 30 second chair stand involves recording the number of stands a person can complete in 30 seconds.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in gait speed
Assesses walking speed in meters per second over a short duration . The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Positive Aspects of Caregiving (PAC) Scale
The 9-item PAC scale will be administered to the caregivers. Each item is scored on a 5-point Likert scale: disagree a lot (1), disagree a little (2), neither agree nor disagree (3), agree a little (4), and agree a lot (5). The overall PAC score, comprising all nine items, ranges from 9 to 45-a higher score reflects a more positive perception of the caregiving experience.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Pearlin Caregiver Stress Scale
Pearlin Caregiver Stress Scale topics include primary stressors (cognitive status, problematic behavior, overload, relational deprivation), secondary role strains family conflict, job-caregiving conflict, economic strains), secondary instrapsychic strains (role captivity, loss of self, caregiving competence, personal gain) and mediators (management of situation, management of meaning, management of distress, expressive support). Fifteen 3-point to 5-point scales.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Zarit Burden Interview
The Zarit Burden Interview, a caregiver self-report measure is a 22-item self-report inventory that examines burden associated with functional/behavioral impairments and the home care situation. Each question is scored on a 5 point Likert scale ranging from 0 (Never) to 4 (Nearly Always).. Total scores range from 0 (low burden) to 88 (high burden).
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Center for Epidemiologic Studies Depression Scale (CES-D)
The CESD-R is a screening test for depression and depressive disorder. The 20 items in CESDR scale measure symptoms of depression in nine different groups as defined by the American Psychiatric Association. The response values for each question are:
Not at all or less than one day = 0 1-2 days = 1 3-4 days = 2 5-7 days = 3 Nearly every day for 2 weeks = 4 The Total CESD-R Score is calculated as a sum of responses to all 20 questions.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in DEMQOL: Dementia Quality of Life measure (Carer v4)
DEMQOL is a 29-item scale, plus one global item ("Overall, how would you rate your quality of life?") that measures 5 domains of QOL: Positive Affect (6 items), Negative Affect (11 items), Feelings of Belonging (3 items), Self-esteem (4 items), and Sense of Aesthetics (5 items). The DQoL yields scores on 5 subscales but subscale scores are not summed to reach an overall or global measure of QOL.
Measured: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start19 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Madeleine Eve Hackney, Emory University
- Investigators
- Madeleine Hackney, Principal investigator, School Of Medicine, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269149
- Sponsor's protocol ID
- IRB00097348
- Status last verified
- May 2026
- First submitted
- 30 Aug 2017
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adapted Tango on African-American Women Caregivers of Alzheimer's Disease Patients
- ClinicalTrials.gov ID
- NCT03269149
- Acronym / sponsor ID
- IRB00097348
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, African-American Women, Caregivers, Tango, Dance-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 31 Aug 2017 (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.
The goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in African American (AA) female family caregivers, at high risk for Alzheimer's disease (AD).
Detailed description
The importance of informal family caregiving in Alzheimer's disease (AD) is well-established. African-American caregivers are most often middle aged adult children of AD patients (vs. spouses), women, and are at higher risk for chronic health problems. AD lifestyle interventions offer an alternative to medication, and are generally affordable, accessible, and adaptable to the lives of caregivers. To date, most non-pharmaceutical interventions have focused on exercise and nutrition, both of which have proven to be highly successful in conferring AD related benefits and decreasing AD risk.
The goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in African American (AA) female family caregivers, at high risk for Alzheimer's disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Tango Dance | Experimental | Other: Adapted Tango Dance20 improvisational, 90-minute adapted tango dance sessions over a 12-week period. |
| Educational Control | Active comparator | Behavioral: Educational lecturesParticipants will take part in at least 20 educational lectures offered twice per week over 12 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women family caregivers from the Emory ADRC and Dr. Wharton's studies of Alzheimer's disease (AD) caregivers
- Parental diagnosis 'probable AD'
- African-American
- 45-65 years of age
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Adapted Tango Dance20 improvisational, 90-minute adapted tango dance sessions over a 12-week period. Classes begin with a 20-minute standing warm-up followed by partnering and rhythmic exercises. Next, novel step elements are introduced and participants will be taught how to combine the new steps with previously learned steps via improvisation. Caregivers will dance with each other or undergraduate /graduate student volunteers. Music will be played throughout classes and artistic expression, i.e., attention to aesthetics, and improvisation, will be encouraged. | Other | Adapted Tango Dance |
| Educational lecturesParticipants will take part in at least 20 educational lectures offered twice per week over 12 weeks. Classes will also be 1.5 hours long and will involve lecture, partnered and group learning and extensive Q\&A will be encouraged. | Behavioural | Educational Control |
Primary outcome
Change in interleukin-7
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in interleukin-8
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in interleukin-9
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in Interleukin-10
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in interferon induced protein 10
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in macrophage derived chemokine
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in monocyte chemoattractant protein 1
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in transforming growth factor alpha
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in tumor necrosis factor alpha
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in C-reactive protein
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
Change in serum amyloid protein
Time frame: Before and after the intervention / control at least 20 times during 12 weeks
45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
17 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA)
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Tower of London test
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Stroop interference test
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Trails B test
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Digit Span test
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Buschke Selective Reminding Test
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Reverse Corsi Blocks test
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Brooks spatial memory test
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Body position spatial task (BPST)
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Fullerton Advanced Balance Scale
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in 30-second chair stand
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in gait speed
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Positive Aspects of Caregiving (PAC) Scale
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in Pearlin Caregiver Stress Scale
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Zarit Burden Interview
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Change in DEMQOL: Dementia Quality of Life measure (Carer v4)
Time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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.
Madeleine Hackney principal investigator
School Of Medicine, Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Tango Dance and Educational lectures in people with Alzheimer's Disease, run by Emory University 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 0 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 26 May 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in interleukin-7 (time frame: Before and after the intervention / control at least 20 times during 12 weeks). 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 26 May 2026.