Mild Cognitive ImpairmentMCI PLIENCT03526146
Preventing Loss of Independence Through Exercise (PLIÉ) in Persons With Mild Cognitive Impairment (MCI)
A study testing Behavioral: Preventing Loss of Independence through Exercise (PLIE) in people with Mild Cognitive Impairment, run by University of California, San Francisco at 1 site in United States.
Trial summary
Nearly 1 in 10 older Americans have dementia, which is a devastating condition that leads to a progressive loss of independence and functional status. Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Behavioral: Preventing Loss of Independence through Exercise (PLIE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Mild Cognitive Impairment (MCI) by primary care physician and/or neurologist
- English language fluency
- willing to attend PLIÉ classes 2 days/week
- ambulatory and able to take 2 steps without cane or walker; living in the community in a private home or apartment
Who cannot join
- Behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., active psychosis, drug abuse, severe behavioral issues)
- Unable to attend 2 PLIÉ classes/week during the study period
- Physical or mental health condition that would make participation difficult (e.g., active psychosis, limited life expectancy)
- Contraindications to magnetic resonance imaging (MRI), including claustrophobia severe enough to prevent MRI examination, and presence of ferrometallic objects in the body that would interfere with MRI examination and/or cause a safety risk (e.g., pace makers, implanted stimulators, pumps).
- Started dementia medication (cholinesterase inhibitor or memantine) in past 3 months
- Planning to start/change any psychotropic medication during the study period
- Current participation in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
Nearly 1 in 10 older Americans have dementia, which is a devastating condition that leads to a progressive loss of independence and functional status. Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. The investigators have developed a novel, integrative exercise program called Preventing Loss of Independence through Exercise (PLIE) that incorporates elements from Eastern and Western exercise modalities and is designed to build and maintain the capacity to perform basic functional movements while increasing mindful body awareness and enhancing social connection. Pilot study results suggest that PLIE is associated with meaningful improvements in physical function, cognitive function and quality of life in individuals with dementia, as well as reduced caregiver burden. The goal of the current study is to perform a randomized, controlled trial to test the efficacy of PLIE in older adults who have MCI but who do not yet have dementia. The investigators will also investigate the neural mechanisms underlying PLIE by acquiring brain imaging measures.
Read the detailed description
The goal of the proposed study is to perform a randomized, controlled trial (RCT) to test the efficacy of a novel integrative exercise program called Preventing Loss of Independence through Exercise (PLIE) on function and quality of life in older adults living in the community with Mild cognitive impairment (MCI), which is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia.
Because current dementia medications have minimal impact on function and quality of life and do not stop or slow the disease course, it would be desirable if there were an intervention that could prevent or delay the onset of full-blown dementia. Moreover, there is growing evidence that behavioral interventions such as exercise have a variety of beneficial effects in individuals with dementia and MCI.
PLIE was developed based on recent discoveries in neuroscience and experimental psychology that have found that, although explicit memory (the ability to consciously recall new information) is impaired in individuals with dementia, implicit memory (unconscious learning that typically occurs through repeated exposure) is relatively preserved. Therefore, PLIE focuses on training procedural memory (unconscious learning of procedures) to build the strength and capacity to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing). In addition, to maximize the benefits of the training, PLIE integrates elements of Eastern and Western exercise modalities to develop mindful body awareness and enhance social connection.
The investigators have completed a pilot study of the PLIE program at an adult day center in San Francisco, CA. Results suggest that PLIE was associated with clinically meaningful improvements in cognitive function, physical performance and quality of life as well as reduced caregiver burden when compared with usual care at the facility. The current study will enable the investigators to build on this pilot study results by performing a RCT of PLIE for individuals who have MCI but who do not yet have dementia.
Study participants will be randomly assigned to receive the PLIE intervention program (1 hour, 2 days/week, 4 months) or Usual Care (UC) control (standard senior center activities, 1 hour, 2 days/week, 4 months) (N=40, 20/group) using a wait-list design. The co-primary outcomes are 4-month change in physical function (Short Physical Performance Battery, SPPB), cognitive function (Alzheimer's Disease Assessment Scale - cognitive subscale, ADAS-cog) and quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). The investigators will also look at the 4-month change in the following neuroimaging measures: brain volume with structural magnetic resonance imaging (MRI), functional connectivity with resting-state functional MRI, cerebral perfusion with arterial-spin labeled MRI. To account for the wait-list design, all outcomes will be assessed at baseline, 4 months and 8 months.
The proposed project will address a critically important health problem related to optimizing functional status and quality of life in older individuals with MCI. The current study will utilize rigorous research methods to test the efficacy of an innovative and promising new program for older adults with MCI. If the program is successful, the investigators will work with VA and community-based organizations to implement PLIE more broadly.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Behavioral: Preventing Loss of Independence through Exercise (PLIE)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Preventing Loss of Independence through Exercise (PLIE)Behavioural
PLIE is an integrative exercise program that focuses on training procedural memory for the ability to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing) while increasing mindful body awareness and encouraging social connection. It combines elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation.
| Study group | Role | What they receive |
|---|---|---|
| PLIE | Experimental | PLIE is an integrative exercise program that focuses on training procedural memory for the ability to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing) while increasing mindful body awareness and encouraging social connection. It combines elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation. Receives: Behavioral: Behavioral: Preventing Loss of Independence through Exercise (PLIE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)
The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) is one of the most commonly used outcome measures in dementia drug treatment trials and is one of the measures considered by the Food and Drug Administration for approval of dementia medications. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. Scores may range from 0 to 70 with higher scores reflecting worse cognitive function. Prior studies have found the ADAS-cog to be valid and reliable with Cronbach's alpha greater than 0.8 and test-retest reliability above 0.9. Because we examined the difference from baseline to post-treatment, a positive change score indicates improvement while a negative change score indicates decline.
Measured: baseline to 12 weeks
Secondary outcomes (4)
Short Physical Performance Battery (SPPB)
The SPPB was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. Lower body strength is assessed based on time to complete 5 chair stands without using arms. Balance is assessed based on the ability to hold different stands for 10 seconds, including the side-by-side, semi-tandem and full tandem stands. Mobility is assessed based on usual walking speed over a 3-meter walking course. The total SPPB score is the sum of the 3 component scores and may range from 0 to 12. Higher scores reflect better performance. Because we examined the difference from baseline to post-treatment, a negative change score indicates improvement while a positive change score indicates decline.
Measured: baseline to 12 weeks
Interoceptive Self-Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
The MAIA is a 37-item self-report questionnaire, consists of eight scales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Interoceptive Self-Regulation, Body Listening, and Trust. To avoid overburdening participants with the entire questionnaire, we will focus on interoceptive self-regulation, the ability to regulate distress by attention to body sensations, which has previously been shown to respond to mindfulness interventions. Interoceptive Self-Regulation scores on the MAIA-2 range from 0-5, with lower scores indicating lower ability to regulate distress by paying attention to body sensations. Because we examined the difference from baseline to post-treatment, a negative change score indicates improvement while a positive change score indicates decline.
Measured: baseline to week 12
Attention Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
The MAIA, a 37-item self-report questionnaire, consists of eight scales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Interoceptive Self-Regulation, Body Listening, and Trust. To avoid overburdening participants with the entire MAIA-2 questionnaire, we focused the ability to sustain and control attention to body sensations (i.e., attention regulation), which has been shown to respond to mindfulness interventions. Attention Regulation scores on the MAIA-2 range from 0-5, with lower scores indicating lower ability to sustain and control attention to body sensations. Because we examined change from baseline to post-treatment, a negative change score indicates improvement in the ability to sustain and control attention to body sensations.
Measured: baseline to week 12
PROMIS Social Isolation
The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation questionnaire assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others with 4 questions (1- I feel left out; 2- I feel that people barely know me; 3- I feel isolated from others; 4-I feel that people are around me but not with me). Subjects respond to each statement with a Likert scale ranging from 1 (never) to 5 (always). Total scores range from 0-20, with higher scores indicating greater feelings of social isolation. Because we calculated a change score (baseline - post-treatment), a positive change score indicates a decrease in feelings of social isolation from baseline to post-treatment.
Measured: baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start30 Aug 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 California, San FranciscoThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study participants will receive the PLIE intervention program (1 hour, 2 days/week, for 12 weeks) at the San Francisco VA.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Linda I Chao, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526146
- Sponsor's protocol ID
- 17-23034
- Acronym
- MCI PLIE
- Status last verified
- Mar 2025
- First submitted
- 3 May 2018
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIE): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015.
PubMed 25671576Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIE): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.935290. Epub 2014 Jul 14.
PubMed 25022459
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Loss of Independence Through Exercise (PLIÉ) in Persons With Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT03526146
- Acronym / sponsor ID
- MCI PLIE / 17-23034
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nearly 1 in 10 older Americans have dementia, which is a devastating condition that leads to a progressive loss of independence and functional status. Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. The investigators have developed a novel, integrative exercise program called Preventing Loss of Independence through Exercise (PLIE) that incorporates elements from Eastern and Western exercise modalities and is designed to build and maintain the capacity to perform basic functional movements while increasing mindful body awareness and enhancing social connection. Pilot study results suggest that PLIE is associated with meaningful improvements in physical function, cognitive function and quality of life in individuals with dementia, as well as reduced caregiver burden. The goal of the current study is to perform a randomized, controlled trial to test the efficacy of PLIE in older adults who have MCI but who do not yet have dementia. The investigators will also investigate the neural mechanisms underlying PLIE by acquiring brain imaging measures.
Detailed description
The goal of the proposed study is to perform a randomized, controlled trial (RCT) to test the efficacy of a novel integrative exercise program called Preventing Loss of Independence through Exercise (PLIE) on function and quality of life in older adults living in the community with Mild cognitive impairment (MCI), which is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia.
Because current dementia medications have minimal impact on function and quality of life and do not stop or slow the disease course, it would be desirable if there were an intervention that could prevent or delay the onset of full-blown dementia. Moreover, there is growing evidence that behavioral interventions such as exercise have a variety of beneficial effects in individuals with dementia and MCI.
PLIE was developed based on recent discoveries in neuroscience and experimental psychology that have found that, although explicit memory (the ability to consciously recall new information) is impaired in individuals with dementia, implicit memory (unconscious learning that typically occurs through repeated exposure) is relatively preserved. Therefore, PLIE focuses on training procedural memory (unconscious learning of procedures) to build the strength and capacity to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing). In addition, to maximize the benefits of the training, PLIE integrates elements of Eastern and Western exercise modalities to develop mindful body awareness and enhance social connection.
The investigators have completed a pilot study of the PLIE program at an adult day center in San Francisco, CA. Results suggest that PLIE was associated with clinically meaningful improvements in cognitive function, physical performance and quality of life as well as reduced caregiver burden when compared with usual care at the facility. The current study will enable the investigators to build on this pilot study results by performing a RCT of PLIE for individuals who have MCI but who do not yet have dementia.
Study participants will be randomly assigned to receive the PLIE intervention program (1 hour, 2 days/week, 4 months) or Usual Care (UC) control (standard senior center activities, 1 hour, 2 days/week, 4 months) (N=40, 20/group) using a wait-list design. The co-primary outcomes are 4-month change in physical function (Short Physical Performance Battery, SPPB), cognitive function (Alzheimer's Disease Assessment Scale - cognitive subscale, ADAS-cog) and quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). The investigators will also look at the 4-month change in the following neuroimaging measures: brain volume with structural magnetic resonance imaging (MRI), functional connectivity with resting-state functional MRI, cerebral perfusion with arterial-spin labeled MRI. To account for the wait-list design, all outcomes will be assessed at baseline, 4 months and 8 months.
The proposed project will address a critically important health problem related to optimizing functional status and quality of life in older individuals with MCI. The current study will utilize rigorous research methods to test the efficacy of an innovative and promising new program for older adults with MCI. If the program is successful, the investigators will work with VA and community-based organizations to implement PLIE more broadly.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study participants will receive the PLIE intervention program (1 hour, 2 days/week, for 12 weeks) at the San Francisco VA.
| Arm | Type | Receives |
|---|---|---|
| PLIE | Experimental | Behavioral: Behavioral: Preventing Loss of Independence through Exercise (PLIE)PLIE is an integrative exercise program that focuses on training procedural memory for the ability to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing) while increasing mindful body awareness and encouraging social connection. It combines elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of Mild Cognitive Impairment (MCI) by primary care physician and/or neurologist
- English language fluency
- willing to attend PLIÉ classes 2 days/week
- ambulatory and able to take 2 steps without cane or walker; living in the community in a private home or apartment
Key exclusion criteria (7 listed)
- Behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., active psychosis, drug abuse, severe behavioral issues)
- Unable to attend 2 PLIÉ classes/week during the study period
- Physical or mental health condition that would make participation difficult (e.g., active psychosis, limited life expectancy)
- Contraindications to magnetic resonance imaging (MRI), including claustrophobia severe enough to prevent MRI examination, and presence of ferrometallic objects in the body that would interfere with MRI examination and/or cause a safety risk (e.g., pace makers, implanted stimulators, pumps).
- Started dementia medication (cholinesterase inhibitor or memantine) in past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Preventing Loss of Independence through Exercise (PLIE)PLIE is an integrative exercise program that focuses on training procedural memory for the ability to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing) while increasing mindful body awareness and encouraging social connection. It combines elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation. | Behavioural | PLIE |
Primary outcome
Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)
Time frame: baseline to 12 weeks
The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) is one of the most commonly used outcome measures in dementia drug treatment trials and is one of the measures considered by the Food and Drug Administration for approval of dementia medications. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. Scores may range from 0 to 70 with higher scores reflecting worse cognitive function. Prior studies have found the ADAS-cog to be valid and reliable with Cronbach's alpha greater than 0.8 and test-retest reliability above 0.9. Because we examined the difference from baseline to post-treatment, a positive change score indicates improvement while a negative change score indicates decline.
4 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: baseline to 12 weeks
Interoceptive Self-Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
Time frame: baseline to week 12
Attention Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
Time frame: baseline to week 12
PROMIS Social Isolation
Time frame: baseline to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25671576Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIE): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015.
- Results publication: PubMed 25022459Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIE): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.935290. Epub 2014 Jul 14.
- Facebook page for PLIE programLink provided by the sponsor.
- Osher Center description of PLIE programLink provided by the sponsor.
- 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.
Linda I Chao, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Preventing Loss of Independence through Exercise (PLIE) in people with Mild Cognitive Impairment, run by University of California, San Francisco 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 7 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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog) (time frame: baseline to 12 weeks). 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 NCT03526146, which also lists 2 linked publications.
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 10 Apr 2025.