Mild Cognitive ImpairmentNCT04522791
Breathing, Relaxation, Attention Training, & Health in Older Adults (BREATHE)
A study testing RFB, VSOP and IR in people with Mild Cognitive Impairment and Healthy Aging, run by University of Rochester at 1 site in United States.
Trial summary
A recently completed study suggested that processing speed and attention (PS/A) oriented cognitive training (VSOP) produced robust effect on PS/A and working memory, but not in cognitive control or episodic memory, and long-term effects were overall modest. Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Mild Cognitive Impairment, Healthy Aging
- What is being tested?
- RFB, VSOP and IR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 19 Feb 2026
- 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 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants will require a diagnosis of "mild cognitive impairment due to Alzheimer's disease"using the most recent NIA and Alzheimer's Association workshop criteria:
- Presence of memory complaint,
- Rey Auditory Verbal Learning Test delayed recall (for memory) < 6,
- Montreal Cognitive Assessment (for global cognition) ranged 18 and 25,
- Activities of Daily Living Questionnaire ≤ 30,
- Intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
Show all 11Show fewer
- If a participant is on Alzheimer's disease medication (i.e., memantine or cholinesterase inhibitors), antidepressants, anxiolytics, or vascular risk or diseases related medications (e.g., beta- blocker), the dose should be stable for 3 months prior to recruitment.
- Age 60-89,
- English-speaking,
- Adequate visual and hearing acuity for using mobile-based apps and testing by self-report, and
- Community-dwelling.
Who cannot join
- Current enrollment in another cognitive improvement study;
- Uncontrollable symptoms of major depression;
- Major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction);
- Neurological diseases (e.g., Parkinson's disease, Multiple Sclerosis);
- Having an active legal guardian (indicating impaired capacity for decision making);
- MRI contraindication (e.g., pacemaker, claustrophobia).
- Color blindedness
- Alcohol dependency in the past 5 years that are the main contributor to MCI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breathing, Relaxation, Attention Training, & Health in Older Adults
A recently completed study suggested that processing speed and attention (PS/A) oriented cognitive training (VSOP) produced robust effect on PS/A and working memory, but not in cognitive control or episodic memory, and long-term effects were overall modest. The proposed R01 renewal proposes to identify additional attributes to further enhance transferred and long-term effects of PS/A training in older adults with amnestic mild cognitive impairment (MCI) by addressing adaptation capacity that underpins adaptive learning and neuroplasticity. The goal of the stage II double-blinded randomized trial is to test whether adding resonance frequency breathing (RFB) training to VSOP will strengthen multiple contributors to adaptation capacity, particularly the central and peripheral pathways of autonomic nervous system (ANS) flexibility, which will strengthen VSOP training effect on cognitive and brain function and slow the progress of dementia in MCI. The central hypothesis is that strengthening adaptation capacity, via improving autonomic nervous system (ANS) flexibility, will enhance neuroplasticity and slow progress of dementia in MCI, since adaptation capacity is critical for neuroplasticity of VSOP, but compromised in neurodegenerative process. Older adults with MCI (n = 114) will be randomly assigned to an 8-week combined intervention (RFB+VSOP), VSOP with guided imagery relaxation (IR) control, and a waitlist IR control, with periodical booster training sessions at follow-ups. Mechanistic and distal outcomes include ANS flexibility and multiple markers of dementia progress. Data will be collected across a 14-month period. The two primary aims are to examine long-term effects of the combined intervention on ANS flexibility (Aim 1), as well as the cognitive, behavioral, and functional capacity (Aim 2). The exploratory aim will be to determine the preliminary long-term effect of the combined intervention on neurodegeneration. This can be a reasonable renewal plan from the completed study, aiming to identify additional attributes to further enhance transferred and long-term effects of cognitive training in MCI. This will be among the first randomized controlled trials to examine a novel, combined intervention targeting adaptation capacity in MCI, with an ultimate goal for slowing neurodegeneration.
In addition, research on how to monitor adherence - the extent to which VSOP training is delivered and followed as intended - has been conceptually and methodologically limited. Robust monitoring of adherence to cognitive training requires valid assessment of effective engagement. Here, we apply our well-supported, novel framework of mental fatigability for measuring effective engagement in cognitive training. Mental fatigability, the failure to remain engaged in tasks requiring sustained mental effort, can be captured via measures of self-reported disengagement, increase in reaction time during tasks, and facial expression of negative valence/low arousal. These markers of disengagement relate to ventromedial prefrontal cortex dysfunction. We will apply this framework to advance understanding of the underpinnings of adherence to VSOP training by monitoring the extent of effective engagement while using the training platform.
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Being tested
- RFB, VSOP, IR
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFBBehavioural
The RFB protocol entails a combination of 8 weekly, in-lab training sessions using HRV biofeedback software (Physiocom, Seattle, WA) and daily paced breathing homework using a mobile-based HRV biofeedback app (Inner Balance, HeartMath, LLC, CA).
VSOPBehavioural
The investigators will use the INSIGHT online program (Posit Science). The platform will be built for our study, including 5 tasks (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice different cognitive processes with PS/A as the shared domain.
IRBehavioural
Guided imagery relaxation, equal in dose and frequency to RF practice, will be used to control for relaxation effects that may occur via RFB (which could provide an alternative explanation for outcomes). IR activities will be facilitated using the Insight Timer mobile-based app, which emphasizes the use of visualization and imagery strategies to help the body relax.
| Study group | Role | What they receive |
|---|---|---|
| RFB+VSOP (MCI) | Experimental | For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.
A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions. Receives: Behavioral: RFB; Behavioral: VSOP |
| IR+VSOP (MCI) | Active comparator | The control IR strategy will be used, set-up of which will be the same as the RFB + VSOP intervention group with IR replacing RFB. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions. Receives: Behavioral: VSOP; Behavioral: IR |
| IR only (MCI) | Placebo comparator | Participants randomized to this condition will receive weekly in-person check-in visits, and perform daily 10-minute IR, so that the number of treatment contacts (though not duration) will be equivalent. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions. Receives: Behavioral: IR |
| RFB+VSOP (HC) | Other | this is a new healthy control intervention arm used for testing adherence related items.
For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.
A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions. Receives: Behavioral: RFB; Behavioral: VSOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of ANS flexibility at 2 months from baseline
A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.
Measured: 2 months post-baseline
change of ANS flexibility at 8 months from baseline
A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.
Measured: 8 months post-baseline
change of ANS flexibility at 14 months from baseline
A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.
Measured: 14 months post-baseline
change of cognition at 2 months from baseline
A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated.
Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated.
A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.
Measured: 2 months post-baseline
change of cognition at 8 months from baseline
A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated.
Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated.
A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.
Measured: 8 months post-baseline
change of cognition at 14 months from baseline
A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated.
Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated.
A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.
Measured: 14 months post-baseline
Secondary outcomes (3)
change of instrumental activities of daily living function (IADL) at 2 months from baseline
Timed IADL objectively measures performance speed and accuracy on multiple IADL domains. Time spent on each task will be recorded with adjustment on whether an individual accurately completed each task. Average completion time across the tasks will be used as the outcome measure; lower completion times indicate lower IADL function. No min/max
Measured: 2 months post-baseline
change of instrumental activities of daily living function (IADL) at 8 months from baseline
Timed IADL objectively measures performance speed and accuracy on multiple IADL domains. Time spent on each task will be recorded with adjustment on whether an individual accurately completed each task. Average completion time across the tasks will be used as the outcome measure; lower completion times indicate lower IADL function. No min/max
Measured: 8 months post-baseline
change of instrumental activities of daily living function (IADL) at 14 months from baseline
Timed IADL objectively measures performance speed and accuracy on multiple IADL domains. Time spent on each task will be recorded with adjustment on whether an individual accurately completed each task. Average completion time across the tasks will be used as the outcome measure; lower completion times indicate lower IADL function. No min/max
Measured: 14 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start18 Aug 2020
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Model description
- A double-blinded, stage 2 randomized controlled trial (RCT). Older adults with MCI (n=114) will be randomly assigned to an 8-week combined intervention (RFB+VSOP), VSOP with imagery-guided relaxation control (IR+VSOP), or a IR control (IR only), with 2-week booster sessions provided at 3- and 9-months after intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Kathi Heffner, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522791
- Sponsor's protocol ID
- STUDY00004727
- Other IDs
- R01NR015452
- Status last verified
- Jun 2026
- First submitted
- 10 Aug 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin FV, Heffner K, Gevirtz R, Zhang Z, Tadin D, Porsteinsson A. Targeting autonomic flexibility to enhance cognitive training outcomes in older adults with mild cognitive impairment: study protocol for a randomized controlled trial. Trials. 2021 Aug 23;22(1):560. doi: 10.1186/s13063-021-05530-z.
PubMed 34425878
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing, Relaxation, Attention Training, & Health in Older Adults
- ClinicalTrials.gov ID
- NCT04522791
- Acronym / sponsor ID
- STUDY00004727
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Stanford University, National Institute of Nursing Research (NINR)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 21 Aug 2020 (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.
A recently completed study suggested that processing speed and attention (PS/A) oriented cognitive training (VSOP) produced robust effect on PS/A and working memory, but not in cognitive control or episodic memory, and long-term effects were overall modest. The proposed R01 renewal proposes to identify additional attributes to further enhance transferred and long-term effects of PS/A training in older adults with amnestic mild cognitive impairment (MCI) by addressing adaptation capacity that underpins adaptive learning and neuroplasticity. The goal of the stage II double-blinded randomized trial is to test whether adding resonance frequency breathing (RFB) training to VSOP will strengthen multiple contributors to adaptation capacity, particularly the central and peripheral pathways of autonomic nervous system (ANS) flexibility, which will strengthen VSOP training effect on cognitive and brain function and slow the progress of dementia in MCI. The central hypothesis is that strengthening adaptation capacity, via improving autonomic nervous system (ANS) flexibility, will enhance neuroplasticity and slow progress of dementia in MCI, since adaptation capacity is critical for neuroplasticity of VSOP, but compromised in neurodegenerative process. Older adults with MCI (n = 114) will be randomly assigned to an 8-week combined intervention (RFB+VSOP), VSOP with guided imagery relaxation (IR) control, and a waitlist IR control, with periodical booster training sessions at follow-ups. Mechanistic and distal outcomes include ANS flexibility and multiple markers of dementia progress. Data will be collected across a 14-month period. The two primary aims are to examine long-term effects of the combined intervention on ANS flexibility (Aim 1), as well as the cognitive, behavioral, and functional capacity (Aim 2). The exploratory aim will be to determine the preliminary long-term effect of the combined intervention on neurodegeneration. This can be a reasonable renewal plan from the completed study, aiming to identify additional attributes to further enhance transferred and long-term effects of cognitive training in MCI. This will be among the first randomized controlled trials to examine a novel, combined intervention targeting adaptation capacity in MCI, with an ultimate goal for slowing neurodegeneration.
In addition, research on how to monitor adherence - the extent to which VSOP training is delivered and followed as intended - has been conceptually and methodologically limited. Robust monitoring of adherence to cognitive training requires valid assessment of effective engagement. Here, we apply our well-supported, novel framework of mental fatigability for measuring effective engagement in cognitive training. Mental fatigability, the failure to remain engaged in tasks requiring sustained mental effort, can be captured via measures of self-reported disengagement, increase in reaction time during tasks, and facial expression of negative valence/low arousal. These markers of disengagement relate to ventromedial prefrontal cortex dysfunction. We will apply this framework to advance understanding of the underpinnings of adherence to VSOP training by monitoring the extent of effective engagement while using the training platform.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A double-blinded, stage 2 randomized controlled trial (RCT). Older adults with MCI (n=114) will be randomly assigned to an 8-week combined intervention (RFB+VSOP), VSOP with imagery-guided relaxation control (IR+VSOP), or a IR control (IR only), with 2-week booster sessions provided at 3- and 9-months after intervention.
| Arm | Type | Receives |
|---|---|---|
| RFB+VSOP (MCI) | Experimental | Behavioral: RFB, Behavioral: VSOPFor home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions. |
| IR+VSOP (MCI) | Active comparator | Behavioral: VSOP, Behavioral: IRThe control IR strategy will be used, set-up of which will be the same as the RFB + VSOP intervention group with IR replacing RFB. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions. |
| IR only (MCI) | Placebo comparator | Behavioral: IRParticipants randomized to this condition will receive weekly in-person check-in visits, and perform daily 10-minute IR, so that the number of treatment contacts (though not duration) will be equivalent. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions. |
| RFB+VSOP (HC) | Other | Behavioral: RFB, Behavioral: VSOPthis is a new healthy control intervention arm used for testing adherence related items. For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All participants will require a diagnosis of "mild cognitive impairment due to Alzheimer's disease"using the most recent NIA and Alzheimer's Association workshop criteria:
- Intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
- If a participant is on Alzheimer's disease medication (i.e., memantine or cholinesterase inhibitors), antidepressants, anxiolytics, or vascular risk or diseases related medications (e.g., beta- blocker), the dose should be stable for 3 months prior to recruitment.
- Age 60-89,
- English-speaking,
Key exclusion criteria (8 listed)
- Current enrollment in another cognitive improvement study;
- Uncontrollable symptoms of major depression;
- Major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction);
- Neurological diseases (e.g., Parkinson's disease, Multiple Sclerosis);
- Having an active legal guardian (indicating impaired capacity for decision making);
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 |
|---|---|---|
| RFBThe RFB protocol entails a combination of 8 weekly, in-lab training sessions using HRV biofeedback software (Physiocom, Seattle, WA) and daily paced breathing homework using a mobile-based HRV biofeedback app (Inner Balance, HeartMath, LLC, CA). | Behavioural | RFB+VSOP (HC), RFB+VSOP (MCI) |
| VSOPThe investigators will use the INSIGHT online program (Posit Science). The platform will be built for our study, including 5 tasks (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice different cognitive processes with PS/A as the shared domain. | Behavioural | IR+VSOP (MCI), RFB+VSOP (HC), RFB+VSOP (MCI) |
| IRGuided imagery relaxation, equal in dose and frequency to RF practice, will be used to control for relaxation effects that may occur via RFB (which could provide an alternative explanation for outcomes). IR activities will be facilitated using the Insight Timer mobile-based app, which emphasizes the use of visualization and imagery strategies to help the body relax. | Behavioural | IR only (MCI), IR+VSOP (MCI) |
Primary outcome
change of ANS flexibility at 2 months from baseline
Time frame: 2 months post-baseline
A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.
change of ANS flexibility at 8 months from baseline
Time frame: 8 months post-baseline
A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.
change of ANS flexibility at 14 months from baseline
Time frame: 14 months post-baseline
A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.
change of cognition at 2 months from baseline
Time frame: 2 months post-baseline
A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated. Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated. A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.
change of cognition at 8 months from baseline
Time frame: 8 months post-baseline
A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated. Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated. A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.
change of cognition at 14 months from baseline
Time frame: 14 months post-baseline
A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated. Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated. A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.
3 secondary outcomes
change of instrumental activities of daily living function (IADL) at 2 months from baseline
Time frame: 2 months post-baseline
change of instrumental activities of daily living function (IADL) at 8 months from baseline
Time frame: 8 months post-baseline
change of instrumental activities of daily living function (IADL) at 14 months from baseline
Time frame: 14 months post-baseline
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 4 Jun 2026.
- Derived from this study: PubMed 34425878Lin FV, Heffner K, Gevirtz R, Zhang Z, Tadin D, Porsteinsson A. Targeting autonomic flexibility to enhance cognitive training outcomes in older adults with mild cognitive impairment: study protocol for a randomized controlled trial. Trials. 2021 Aug 23;22(1):560. doi: 10.1186/s13063-021-05530-z.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFB, VSOP and IR in people with Mild Cognitive Impairment and Healthy Aging, run by University of Rochester 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 11 inclusion and 8 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 4 Jun 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. 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?
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 of ANS flexibility at 2 months from baseline (time frame: 2 months post-baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522791, which also lists 1 linked publication.
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 4 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.