ApathyTAMCINCT03590327
Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
A study testing Transcranial Magnetic Stimulation in people with Apathy and Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apathy, Mild Cognitive Impairment, Transcranial Magnetic Stimulation
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 Oct 2024
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- meeting the modified Mayo Clinic criteria for MCI
- Having caregivers
- apathy threshold (NPI)
- MMSE 23
- On stable dose of antidepressants for at least a month (if applicable)
Who cannot join
- PHASE I
- Uncontrolled diabetes mellitus (Fasting BS>200mg/dl, HbA1c>10)
- Renal disease requiring dialysis
- Uncontrolled blood pressure (>160/100, <100 systolic)
- Metastatic cancer or undergoing chemotherapy
- Deep venous thrombosis or myocardial infarction in past 3 months
Show all 27Show fewer
- Uncontrolled malignant cardiac arrhythmia
- Cerebral aneurysm or intracranial bleed in past year
- Unstable angina in past month
- Unstable abdominal or thoracic aortic aneurysm (>4cm)
- End-stage congestive heart failure
- EXCLUSIONARY DUE TO rTMS: ALL PHASE II AND SUBSET OF PHASE I THAT RECEIVE SINGLE SESSION rTMS
- Taking medications known to increase risk of seizures from 2012 Beers criteria such as bupropion, chlorpromazine, clozapine.
- Taking other medications known to increase risk of seizures such as tricyclic antidepressants.
- Taking ototoxic medications: Aminoglycosides, Cisplatin
- History of seizures/ seizures in first degree relatives
- Those with implanted device
- History of stroke, aneurysm, or cranial neurosurgery
- History of bipolar disorder
- Current alcohol related disorder needing medical treatment
- History of Tourette's syndrome or presence of motor tics
- History of abnormal electroencephalogram (EEG)
- EXCLUSIONARY DUE TO CONFOUNDING WITH APATHY: PHASE II
- Current episode of Major Depressive Disorder
- Current use of stimulants
- Change in dose of dementia medications within 30 days
- Change in dose of antidepressants within 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, 72205
About this study
Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild memory problems. Their motivation, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the front part of their brain over 20 sessions. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.
A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment.
Read more
Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD.
Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD.
Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.
Read the detailed description
Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild cognitive impairment. Their motivation, other behavioral problems, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the dorsolateral prefrontal cortex over 20 daily sessions on consecutive week days. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.
A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment.
Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD.
Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD.
Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.
- Conditions
- Apathy, Mild Cognitive Impairment, Transcranial Magnetic Stimulation, Loneliness, COVID, Neuropsychiatric Symptoms
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Lethargy, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
rTMS
| Study group | Role | What they receive |
|---|---|---|
| Apathy +, rTMS - | No intervention | This arm will be followed without intervention |
| rTMS | Active comparator | This group will be randomized to receive rTMS treatment Receives: Device: Transcranial Magnetic Stimulation |
| Sham | Sham comparator | This group will be randomized to receive sham treatment Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apathy Evaluation Scale Score
Range 18-72 Lower score is improvement
Measured: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Secondary outcomes (2)
Change in Modified Mini Mental State Examination Score
Range 0-100 Higher score is improvement
Measured: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Change in Conner's Continuous Performance Test Commission Error percentage
Range 0-100% Higher score is improvement
Measured: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Nov 2018
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ApathyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Central Arkansas Veterans Healthcare System, University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Prasad R. Padala, MBBS MBBS, Principal investigator, Central Arkansas Veterans Healthcare System , Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590327
- Sponsor's protocol ID
- D2638-R
- Other IDs
- 1115904
- Acronym
- TAMCI
- Status last verified
- Oct 2025
- First submitted
- 15 May 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sharma T, Padala PR, Mehta JL. Loneliness and Social Isolation: Determinants of Cardiovascular Outcomes. Curr Cardiol Rev. 2021;17(6):e051121190873. doi: 10.2174/1573403X17666210129101845.
PubMed 33511946Padala KP, Jendro AM, Wilson KB, Padala PR. Technology Use to Bridge the Gap of Social Distancing during COVID-19. J Geriatr Med Gerontol. 2020 Jun 29;6(2):10.23937/2469-5858/1510092. doi: 10.23937/2469-5858/1510092. No abstract available.
PubMed 33511321Padala KP, Parkes CM, Padala PR. Neuropsychological and Functional Impact of COVID-19 on Mild Cognitive Impairment. Am J Alzheimers Dis Other Demen. 2020 Jan-Dec;35:1533317520960875. doi: 10.1177/1533317520960875.
PubMed 32969235Padala PR, Boozer EM, Lensing SY, Parkes CM, Hunter CR, Dennis RA, Caceda R, Padala KP. Neuromodulation for Apathy in Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled Pilot Study. J Alzheimers Dis. 2020;77(4):1483-1493. doi: 10.3233/JAD-200640.
PubMed 32925060Preston AM, Padala PR. Virtual reality on the verge of becoming a reality for geriatric research. Int Psychogeriatr. 2022 Feb;34(2):97-99. doi: 10.1017/S1041610221000867. Epub 2021 Jun 8. No abstract available.
PubMed 34099086Mintzer J, Lanctot KL, Scherer RW, Rosenberg PB, Herrmann N, van Dyck CH, Padala PR, Brawman-Mintzer O, Porsteinsson AP, Lerner AJ, Craft S, Levey AI, Burke W, Perin J, Shade D; ADMET 2 Research Group. Effect of Methylphenidate on Apathy in Patients With Alzheimer Disease: The ADMET 2 Randomized Clinical Trial. JAMA Neurol. 2021 Nov 1;78(11):1324-1332. doi: 10.1001/jamaneurol.2021.3356.
PubMed 34570180Mortby ME, Adler L, Aguera-Ortiz L, Bateman DR, Brodaty H, Cantillon M, Geda YE, Ismail Z, Lanctot KL, Marshall GA, Padala PR, Politis A, Rosenberg PB, Siarkos K, Sultzer DL, Theleritis C; ISTAART NPS PIA. Apathy as a Treatment Target in Alzheimer's Disease: Implications for Clinical Trials. Am J Geriatr Psychiatry. 2022 Feb;30(2):119-147. doi: 10.1016/j.jagp.2021.06.016. Epub 2021 Jul 1.
PubMed 34315645Okolichany R, Padala PR, Mooney S. Cognitive and Functional Abilities in an Older Adult Veteran Before and After Contracting COVID-19. J Alzheimers Dis Rep. 2022 Mar 25;6(1):115-120. doi: 10.3233/ADR-210055. eCollection 2022.
PubMed 35530116Preston AM, Brown L, Padala KP, Padala PR. Veterans Affairs Health Care Provider Perceptions of Virtual Reality: Brief Exploratory Survey. Interact J Med Res. 2022 Sep 2;11(2):e38490. doi: 10.2196/38490.
PubMed 36053568
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03590327
- Acronym / sponsor ID
- TAMCI / D2638-R
- Conditions
- Apathy, Mild Cognitive Impairment, Transcranial Magnetic Stimulation, Loneliness, COVID, Neuropsychiatric Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Central Arkansas Veterans Healthcare System, University of Arkansas
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 18 Jul 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.
Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild memory problems. Their motivation, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the front part of their brain over 20 sessions. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.
A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment.
Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD.
Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD.
Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.
Detailed description
Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild cognitive impairment. Their motivation, other behavioral problems, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the dorsolateral prefrontal cortex over 20 daily sessions on consecutive week days. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.
A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment.
Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD.
Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD.
Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apathy +, rTMS - | No intervention | –This arm will be followed without intervention |
| rTMS | Active comparator | Device: Transcranial Magnetic StimulationThis group will be randomized to receive rTMS treatment |
| Sham | Sham comparator | Device: Transcranial Magnetic StimulationThis group will be randomized to receive sham treatment |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- meeting the modified Mayo Clinic criteria for MCI
- Having caregivers
- apathy threshold (NPI)
- MMSE 23
- On stable dose of antidepressants for at least a month (if applicable)
Key exclusion criteria (27 listed)
- PHASE I
- Uncontrolled diabetes mellitus (Fasting BS>200mg/dl, HbA1c>10)
- Renal disease requiring dialysis
- Uncontrolled blood pressure (>160/100, <100 systolic)
- Metastatic cancer or undergoing chemotherapy
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 |
|---|---|---|
| Transcranial Magnetic StimulationrTMS | Device | Sham, rTMS |
Primary outcome
Change in Apathy Evaluation Scale Score
Time frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Range 18-72 Lower score is improvement
2 secondary outcomes
Change in Modified Mini Mental State Examination Score
Time frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Change in Conner's Continuous Performance Test Commission Error percentage
Time frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
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 22 May 2026.
- Background: PubMed 33511946Sharma T, Padala PR, Mehta JL. Loneliness and Social Isolation: Determinants of Cardiovascular Outcomes. Curr Cardiol Rev. 2021;17(6):e051121190873. doi: 10.2174/1573403X17666210129101845.
- Background: PubMed 33511321Padala KP, Jendro AM, Wilson KB, Padala PR. Technology Use to Bridge the Gap of Social Distancing during COVID-19. J Geriatr Med Gerontol. 2020 Jun 29;6(2):10.23937/2469-5858/1510092. doi: 10.23937/2469-5858/1510092. No abstract available.
- Background: PubMed 32969235Padala KP, Parkes CM, Padala PR. Neuropsychological and Functional Impact of COVID-19 on Mild Cognitive Impairment. Am J Alzheimers Dis Other Demen. 2020 Jan-Dec;35:1533317520960875. doi: 10.1177/1533317520960875.
- Background: PubMed 32925060Padala PR, Boozer EM, Lensing SY, Parkes CM, Hunter CR, Dennis RA, Caceda R, Padala KP. Neuromodulation for Apathy in Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled Pilot Study. J Alzheimers Dis. 2020;77(4):1483-1493. doi: 10.3233/JAD-200640.
- Background: PubMed 34099086Preston AM, Padala PR. Virtual reality on the verge of becoming a reality for geriatric research. Int Psychogeriatr. 2022 Feb;34(2):97-99. doi: 10.1017/S1041610221000867. Epub 2021 Jun 8. No abstract available.
- Background: PubMed 34570180Mintzer J, Lanctot KL, Scherer RW, Rosenberg PB, Herrmann N, van Dyck CH, Padala PR, Brawman-Mintzer O, Porsteinsson AP, Lerner AJ, Craft S, Levey AI, Burke W, Perin J, Shade D; ADMET 2 Research Group. Effect of Methylphenidate on Apathy in Patients With Alzheimer Disease: The ADMET 2 Randomized Clinical Trial. JAMA Neurol. 2021 Nov 1;78(11):1324-1332. doi: 10.1001/jamaneurol.2021.3356.
- Background: PubMed 34315645Mortby ME, Adler L, Aguera-Ortiz L, Bateman DR, Brodaty H, Cantillon M, Geda YE, Ismail Z, Lanctot KL, Marshall GA, Padala PR, Politis A, Rosenberg PB, Siarkos K, Sultzer DL, Theleritis C; ISTAART NPS PIA. Apathy as a Treatment Target in Alzheimer's Disease: Implications for Clinical Trials. Am J Geriatr Psychiatry. 2022 Feb;30(2):119-147. doi: 10.1016/j.jagp.2021.06.016. Epub 2021 Jul 1.
- Background: PubMed 35530116Okolichany R, Padala PR, Mooney S. Cognitive and Functional Abilities in an Older Adult Veteran Before and After Contracting COVID-19. J Alzheimers Dis Rep. 2022 Mar 25;6(1):115-120. doi: 10.3233/ADR-210055. eCollection 2022.
- Background: PubMed 36053568Preston AM, Brown L, Padala KP, Padala PR. Veterans Affairs Health Care Provider Perceptions of Virtual Reality: Brief Exploratory Survey. Interact J Med Res. 2022 Sep 2;11(2):e38490. doi: 10.2196/38490.
- 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.
Prasad R. Padala, MBBS MBBS principal investigator
Central Arkansas Veterans Healthcare System , Little Rock, AR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Apathy and Mild Cognitive Impairment, run by VA Office of Research and Development 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 5 inclusion and 27 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 in Apathy Evaluation Scale Score (time frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months). 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 NCT03590327, which also lists 9 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 22 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.