Cognition DisordersCogExNCT03696082
A Precision Rehabilitation Approach to Counteract Age-Related Cognitive Declines
A study testing Aerobic Activity, Resistance Training and Yoga in people with Cognition Disorders and Brain Pathology, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study examines the behavioral, molecular, and structural biomarkers of brain health that will allow for the stratification of individuals according to their "cognitive signature" and function. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders, Brain Pathology, Physical Disability
- What is being tested?
- Aerobic Activity, Resistance Training and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Dec 2022
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-80 years.
- Sedentary, which is defined as regular participation over the past 3 months in <60 minutes per week of moderate-to-vigorous leisure-time or transportation-related physical activity performed in bouts of >10 minutes.
- Independent ambulation without or with an cane or walking stick.
- Able to walk (with or without assistive device such as a cane or walking stick) a distance of at least 400 meters based on self-report.
- The ability to provide clearance from a physician for participation in the assessments and intervention aspects of this study.
- Ability to provide informed consent.
Who cannot join
- Reporting engaging in regular aerobic exercise, resistance exercise, or yoga exercise over the prior 3 months.
- History of stroke, uncontrolled resting hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg), congestive heart failure, recent myocardial infarction, or other contraindications to engagement in moderate-intensity physical activity for at least 10 continuous minutes.
- Incompatibility with the MRI environment (e.g. claustrophobia, metal implants, or body size, etc.)
- Inability to attend the sessions as prescribed.
- Consuming >1 alcoholic drink per day on >4 days per week, or current treatment for substance use disorder.
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments.
Show all 15Show fewer
- Use of a walker or rolling walker for ambulation.
- SPPB score of <6 or unable to perform any of the 3 components of the total score [item score = 0].
- Inability to complete the 400m walk test; or an unhealthy response to test [e.g., Systolic blood pressure >240 or diastolic blood pressure >115; or a drop in diastolic blood pressure > 10mm].
- Depressive symptoms not controlled or treated.
- List the medications that will exclude a participant (e.g., those that may complicate brain imaging, cognitive test, or biomarker testing or interpretation).
- Degenerative neurological condition [e.g., Parkinson's Disease, multiple sclerosis].
- Severe respiratory disease [eg COPD with shortness of breath], or use of supplemental oxygen.
- Lower limb below or above knee amputation / prosthesis.
- Score of <85 of the 3MS (Modified Mini-Mental State Exam).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: A Precision Rehabilitation Approach to Counteract Age-Related Cognitive
This study examines the behavioral, molecular, and structural biomarkers of brain health that will allow for the stratification of individuals according to their "cognitive signature" and function. This study will randomize older adults into one of four interventions for a period of 12 months: 1) Aerobic Exercise, 2) Resistance Exercise, 3) Yoga Exercise, 4) Health Education (involves stretching and range of motion activities). This aims of this study will examine whether and how these different types of training interventions exert effects cognitive function, brain structure, biomarkers of brain health and cognition, and physical function.
Read the detailed description
Physical activity is increasingly recognized to play a role in maintenance of brain health and attenuation of physical decline associated with aging. While physical activity has been shown to gradually decline with increasing age, initiation of an exercise protocol attenuates declines in cognition associated with advancing age, including impaired neurogenesis as well as decreased attention and learning. These benefits may be attributed, at least in part, to physical activity's role in maintaining an anti-inflammatory phenotype, and several clinical observational studies performed in older adults have shown an inverse relationship between self-reported physical activity and inflammatory biomarkers. Pre-clinical studies have also revealed that exposing aged animals to circulating factors derived from young animal counterparts significantly improves cognitive function and promotes neurogenesis.
A major limitation of clinical studies investigating the effect of physical activity on cognitive function is that subjects display considerable variability in their responses to the intervention. There are likely to be multiple biological pathways by which physical activity influences brain structure and function, and the type of physical activity that may be effective for influencing these pathways is likely to vary greatly. A better mechanistic understanding of how different modes of physical activity may target varying regions of the brain and other aspects of aging is therefore warranted.
This study examines the behavioral, molecular, and structural biomarkers of brain health that will allow for the stratification of individuals according to their "cognitive signature" and function. This study will randomize older adults into one of four interventions for a period of 12 months: 1) Aerobic Exercise, 2) Resistance Exercise, 3) Yoga Exercise, 4) Health Education (involves stretching and range of motion activities).
This aims of this study will examine whether and how these different types of training interventions exert differential effects on potential pathways of cognition and function in aged individuals, and the role of baseline subject characteristics in mediating these responses. The specific aims are:
- To compare changes in cognitive function in response to three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- To compare changes in brain structure in response to three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- To compare biomarkers of brain health and cognition in response to three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- To examine changes in physical function in response to three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- To conduct post-hoc analyses to examine whether baseline measures of cognitive function, brain structure, biomarkers, or physical function influence responsiveness to any of the three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- Being tested
- Aerobic Activity, Resistance Training, Yoga, Health Education
- Medical subject headings
- Cognition Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ActivityBehavioural
Moderate-intensity exercise aerobic exercise that involves participating in activities similar to brisk walking that increase heart rate and breathing rate, with activity progressing to 150 minutes per week. Activities other than brisk walking, such as dance, aerobics, swimming, cycling or other activities that increase heart rate and breathing rate to a moderate intensity that can be sustained for at least 10 minutes will also be encouraged. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.
Resistance TrainingBehavioural
Resistance exercise that involves participating in activities similar to lifting weights that cause the participant to work specific muscles of your body, with activity progressing to 150 minutes per week. This can involve using weight training machines, elastic tubes that create resistance, or weights such a dumbbells. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.
YogaBehavioural
Yoga involves a series of movements and poses that are performed in a specific sequence that are adapted to your ability, with activity progressing to 150 minutes per week. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.
Health EducationBehavioural
This involves the participant receiving information regarding aspects of health that are important for older adults, and also physical activity in the form of light stretching activities and movements. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Activity | Experimental | Moderate-intensity exercise aerobic exercise that involves participating in activities similar to brisk walking that increase heart rate and breathing rate, with activity progressing to 150 minutes per week. Activities other than brisk walking, such as dance, aerobics, swimming, cycling or other activities that increase heart rate and breathing rate to a moderate intensity that can be sustained for at least 10 minutes will also be encouraged. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. Receives: Behavioral: Aerobic Activity |
| Resistance Training | Experimental | Resistance exercise that involves participating in activities similar to lifting weights that cause the participant to work specific muscles of your body, with activity progressing to 150 minutes per week. This can involve using weight training machines, elastic tubes that create resistance, or weights such a dumbbells. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. Receives: Behavioral: Resistance Training |
| Yoga | Experimental | Yoga involves a series of movements and poses that are performed in a specific sequence that are adapted to your ability, with activity progressing to 150 minutes per week. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. Receives: Behavioral: Yoga |
| Health Education | Experimental | This involves the participant receiving information regarding aspects of health that are important for older adults, and also physical activity in the form of light stretching activities and movements. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Brain Structure at 6 and 12 months
Measured used MRI and fMRI tasks.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (11)
Change from Baseline Functional Fitness at 3, 6, and 12 months
Assessed with the Short Physical Performance Battery
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Fitness at 3, 6, and 12 months
Assessed with a 400 meter corridor walk.
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Repeatable Battery for the Assessment of Neuropsychological Status at 3, 6, and 12 months
This is a brief standardized paper-and-pencil neurocognitive battery measuring immediate and delayed memory, attention, language, and visuospatial skills. The test comprises of 12 subtests that is administered by a trained examiner.
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Modified Mini-Mental Status Exam at 3, 6, and 12 months
This is an expanded 100-point version of the original Mini-Mental Status Exam, administered in ~7 minutes, which assesses global cognitive function. This measure has very good reliability, validity, and sensitivity to moderate cognitive changes and has a proven record in clinical trials.
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Auditory Verbal Learning Test at 3, 6, and 12 months
The participant is read a list of 15 words, 5 times. After each time, the participant is asked to immediately recall as many words as possible. Following the 5th recall, an interference list is presented, after which the participant is asked to spontaneously recall words from the original list. After a 10-minute interval has passed, the participant is asked again to recall as many words as possible from the original list.
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Physical Activity (minutes per week) at 3, 6, and 12 months
Measured by Actigraphy
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Physical Activity (minutes per week) at 3, 6, and 12 months
Measured by CHAMPS questionnaire.
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Physical Activity (minutes per week) at 3, 6, and 12 months
Measured by Paffenbarger questionnaire.
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Sedentary Behavior (minutes per day) at 3, 6, and 12 months
Measured by modified CARDIA questionnaire
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Sedentary Behavior (minutes per day) at 3, 6, and 12 months
Measured by Actigraphy
Measured: Baseline, 3 months, 6 months, 12 months
Change from Baseline Peripheral biomarkers at 3, 6, and 12 months
Assessed from venous blood collection and includes measures of neuroinflammation, neurogenesis, and cerebral vascularity
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Sep 2018
- Primary completion31 Jan 2022
- Study completion31 Dec 2022
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrisia Ambrosio, University of Pittsburgh
- Investigators
- John M. Jakicic, PhD, Principal investigator, University of PittsburghFabrisia Ambrosio, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696082
- Sponsor's protocol ID
- PRO17100528
- Acronym
- CogEx
- Status last verified
- Mar 2023
- First submitted
- 13 Sep 2018
- Last updated
- 22 Mar 2023
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Precision Rehabilitation Approach to Counteract Age-Related Cognitive
- ClinicalTrials.gov ID
- NCT03696082
- Acronym / sponsor ID
- CogEx / PRO17100528
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Oct 2018 (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 examines the behavioral, molecular, and structural biomarkers of brain health that will allow for the stratification of individuals according to their "cognitive signature" and function. This study will randomize older adults into one of four interventions for a period of 12 months: 1) Aerobic Exercise, 2) Resistance Exercise, 3) Yoga Exercise, 4) Health Education (involves stretching and range of motion activities). This aims of this study will examine whether and how these different types of training interventions exert effects cognitive function, brain structure, biomarkers of brain health and cognition, and physical function.
Detailed description
Physical activity is increasingly recognized to play a role in maintenance of brain health and attenuation of physical decline associated with aging. While physical activity has been shown to gradually decline with increasing age, initiation of an exercise protocol attenuates declines in cognition associated with advancing age, including impaired neurogenesis as well as decreased attention and learning. These benefits may be attributed, at least in part, to physical activity's role in maintaining an anti-inflammatory phenotype, and several clinical observational studies performed in older adults have shown an inverse relationship between self-reported physical activity and inflammatory biomarkers. Pre-clinical studies have also revealed that exposing aged animals to circulating factors derived from young animal counterparts significantly improves cognitive function and promotes neurogenesis.
A major limitation of clinical studies investigating the effect of physical activity on cognitive function is that subjects display considerable variability in their responses to the intervention. There are likely to be multiple biological pathways by which physical activity influences brain structure and function, and the type of physical activity that may be effective for influencing these pathways is likely to vary greatly. A better mechanistic understanding of how different modes of physical activity may target varying regions of the brain and other aspects of aging is therefore warranted.
This study examines the behavioral, molecular, and structural biomarkers of brain health that will allow for the stratification of individuals according to their "cognitive signature" and function. This study will randomize older adults into one of four interventions for a period of 12 months: 1) Aerobic Exercise, 2) Resistance Exercise, 3) Yoga Exercise, 4) Health Education (involves stretching and range of motion activities).
This aims of this study will examine whether and how these different types of training interventions exert differential effects on potential pathways of cognition and function in aged individuals, and the role of baseline subject characteristics in mediating these responses. The specific aims are:
- To compare changes in cognitive function in response to three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- To compare changes in brain structure in response to three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- To compare biomarkers of brain health and cognition in response to three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- To examine changes in physical function in response to three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
- To conduct post-hoc analyses to examine whether baseline measures of cognitive function, brain structure, biomarkers, or physical function influence responsiveness to any of the three different types of physical activity (aerobic activity, resistance training activity, yoga) versus health education control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic Activity | Experimental | Behavioral: Aerobic ActivityModerate-intensity exercise aerobic exercise that involves participating in activities similar to brisk walking that increase heart rate and breathing rate, with activity progressing to 150 minutes per week. Activities other than brisk walking, such as dance, aerobics, swimming, cycling or other activities that increase heart rate and breathing rate to a moderate intensity that can be sustained for at least 10 minutes will also be encouraged. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. |
| Resistance Training | Experimental | Behavioral: Resistance TrainingResistance exercise that involves participating in activities similar to lifting weights that cause the participant to work specific muscles of your body, with activity progressing to 150 minutes per week. This can involve using weight training machines, elastic tubes that create resistance, or weights such a dumbbells. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. |
| Yoga | Experimental | Behavioral: YogaYoga involves a series of movements and poses that are performed in a specific sequence that are adapted to your ability, with activity progressing to 150 minutes per week. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. |
| Health Education | Experimental | Behavioral: Health EducationThis involves the participant receiving information regarding aspects of health that are important for older adults, and also physical activity in the form of light stretching activities and movements. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65-80 years.
- Sedentary, which is defined as regular participation over the past 3 months in <60 minutes per week of moderate-to-vigorous leisure-time or transportation-related physical activity performed in bouts of >10 minutes.
- Independent ambulation without or with an cane or walking stick.
- Able to walk (with or without assistive device such as a cane or walking stick) a distance of at least 400 meters based on self-report.
- The ability to provide clearance from a physician for participation in the assessments and intervention aspects of this study.
Key exclusion criteria (15 listed)
- Reporting engaging in regular aerobic exercise, resistance exercise, or yoga exercise over the prior 3 months.
- History of stroke, uncontrolled resting hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg), congestive heart failure, recent myocardial infarction, or other contraindications to engagement in moderate-intensity physical activity for at least 10 continuous minutes.
- Incompatibility with the MRI environment (e.g. claustrophobia, metal implants, or body size, etc.)
- Inability to attend the sessions as prescribed.
- Consuming >1 alcoholic drink per day on >4 days per week, or current treatment for substance use disorder.
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 |
|---|---|---|
| Aerobic ActivityModerate-intensity exercise aerobic exercise that involves participating in activities similar to brisk walking that increase heart rate and breathing rate, with activity progressing to 150 minutes per week. Activities other than brisk walking, such as dance, aerobics, swimming, cycling or other activities that increase heart rate and breathing rate to a moderate intensity that can be sustained for at least 10 minutes will also be encouraged. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. | Behavioural | Aerobic Activity |
| Resistance TrainingResistance exercise that involves participating in activities similar to lifting weights that cause the participant to work specific muscles of your body, with activity progressing to 150 minutes per week. This can involve using weight training machines, elastic tubes that create resistance, or weights such a dumbbells. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. | Behavioural | Resistance Training |
| YogaYoga involves a series of movements and poses that are performed in a specific sequence that are adapted to your ability, with activity progressing to 150 minutes per week. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. | Behavioural | Yoga |
| Health EducationThis involves the participant receiving information regarding aspects of health that are important for older adults, and also physical activity in the form of light stretching activities and movements. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision. | Behavioural | Health Education |
Primary outcome
Change from Baseline Brain Structure at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
Measured used MRI and fMRI tasks.
11 secondary outcomes
Change from Baseline Functional Fitness at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Fitness at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Repeatable Battery for the Assessment of Neuropsychological Status at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Modified Mini-Mental Status Exam at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Auditory Verbal Learning Test at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Physical Activity (minutes per week) at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Physical Activity (minutes per week) at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Physical Activity (minutes per week) at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Sedentary Behavior (minutes per day) at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Sedentary Behavior (minutes per day) at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Change from Baseline Peripheral biomarkers at 3, 6, and 12 months
Time frame: Baseline, 3 months, 6 months, 12 months
Results and safety
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- 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.
John M. Jakicic, PhD principal investigator
University of Pittsburgh
Fabrisia Ambrosio, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Activity, Resistance Training and Yoga in people with Cognition Disorders and Brain Pathology, run by University of Pittsburgh 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Mar 2023. 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 was stopped early (reason given: Funding ended). 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?
Change from Baseline Brain Structure at 6 and 12 months (time frame: Baseline, 6 months, 12 months). 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 22 Mar 2023.