Alzheimer DiseaseNCT04507815
tDCS and Cognitive Training for Mild Cognitive Impairment and Alzheimer's Dementia
A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Alzheimer Disease and Mild Cognitive Impairment, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
There are currently no disease-modifying treatments for cognitive and behavioral symptoms associated with early clinical Alzheimer's disease (AD), and only minimally effective symptomatic treatments are available. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Active Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2020to Sep 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be included in the study if they:
- are a Veteran receiving services from the MVAHCS GRECC clinic
- have a clinical diagnosis of AD, MCI, or Mild Neurocognitive Disorder presenting as early AD type (predominantly amnestic and dysexecutive)
- are age 60 or older
- are stable on any medications for at least 1 month at the baseline visit
- demonstrate capacity to provide informed consent
- have WiFi access in their home
- have a family member or friend willing to serve as a care partner (care partner needs to have a minimum of 10 hours per week that they see the participant, if they don't live with them).
Who cannot join
- Persons will be excluded from this study if they have:
- any significant medical disorder based on the Principal Investigator's judgment that would impact risk
- other psychiatric or neurological conditions that impact cognition
- metallic cranial plates/screws or implanted devices above the clavicle
- eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
About this study
Official title: Combined tDCS and Cognitive Training for Mild Cognitive Impairment (MCI) and Early Clinical Alzheimer's Type Dementia (CATD)
There are currently no disease-modifying treatments for cognitive and behavioral symptoms associated with early clinical Alzheimer's disease (AD), and only minimally effective symptomatic treatments are available. In this application, we propose a transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention will target cognition and brain circuits that are impaired in patients with mild cognitive impairment (MCI) and early AD. The goal is to improve cognitive performance and functional outcomes in patients with MCI and early AD.
Read the detailed description
Objectives There are currently no disease-modifying treatments for cognitive and behavioral symptoms associated with early clinical Alzheimer's disease (AD), and only minimally effective symptomatic treatments are available. In this application, we propose a transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention will target cognition and brain circuits that are impaired in patients with mild cognitive impairment (MCI) and early AD. The goal is to improve cognitive performance and functional outcomes in patients with MCI and early AD.
Research Plan and Methods This study will recruit 50 Veterans with MCI or very early AD who are receiving outpatient services at the Minneapolis VA Health Care System (MVAHCS) Geriatric Research, Education, and Clinical Center (GRECC) Memory Loss Clinic. This study will be a double-blind, randomized, placebo (sham) controlled study. Participants will be randomly assigned to receive either active or sham tDCS, both paired with cognitive training tasks. Ten sessions of training/tDCS sessions (20 minutes of 2mA current stimulation with 45 minutes of cognitive training tasks) will occur over 2-3 weeks, performed at the participant's home. Participants will attend an in-person enrollment and training session prior to study intervention. Follow-up sessions will occur via phone or video conference at 3 and 6 months after study initiation.
Clinical Relevance Executive cognitive impairments in patients with MCI or early AD have been associated with poor decision-making ability and lack of insight, potentially leading to compromised job performance, financial mismanagement, increased personal safety risk, relationship stress, and poor medical treatment adherence. While disproportionate memory impairment is a hallmark of both conditions, there are compensatory strategies available to reduce disability associated with very early stage memory impairment in those who are otherwise cognitively intact. Compensatory strategies are much less effective for executive dysfunction, as the disability itself impairs one's ability to recognize when such strategies are needed and successfully employ them. Novel, well-tolerated, neuroplasticity-based interventions that can reduce executive impairment by targeting both cognitive control (an executive ability) and its underlying neural dysfunction are needed to improve cognitive outcomes, safety, and quality of life for patients with MCI or early AD. Knowledge gained from this study can inform the future development of clinical treatment approaches aimed at reducing risk and delaying out-of-home placement in Veterans with cognitive impairment.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- Active Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current Stimulation (tDCS)Device
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Sham Transcranial Direct Current Stimulation (tDCS)Device
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes). Receives: Device: Active Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS | Sham comparator | Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This ramp up/down method is done at the end of the stimulation period, as well. This method mimics the physical sensation of stimulation typically encountered at the very beginning and end of the intervention period. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Test of Adult Cognition by Telephone (BTACT)
Differences in magnitude of change in BTACT scores between active tDCS and sham groups from baseline to follow-up sessions. BTACT covers five cognitive domains: episodic verbal memory (list learning), working memory span (digits backwards), executive functioning (verbal fluency), inductive reasoning (number series completion), and processing speed (backwards counting). Higher total score on the BTACT indicates better cognitive performance.
Measured: Change between baseline and 3 week follow-up; 3 and 6 months following study baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start24 Sep 2020
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Casey Gilmore, PhD, Minneapolis Veterans Affairs Medical Center
- Investigators
- John R McCarten, MD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507815
- Sponsor's protocol ID
- VAM-20-00623
- Status last verified
- Mar 2023
- First submitted
- 7 Aug 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined tDCS and Cognitive Training for Mild Cognitive Impairment (MCI) and Early Clinical Alzheimer's Type Dementia (CATD)
- ClinicalTrials.gov ID
- NCT04507815
- Acronym / sponsor ID
- VAM-20-00623
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 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.
There are currently no disease-modifying treatments for cognitive and behavioral symptoms associated with early clinical Alzheimer's disease (AD), and only minimally effective symptomatic treatments are available. In this application, we propose a transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention will target cognition and brain circuits that are impaired in patients with mild cognitive impairment (MCI) and early AD. The goal is to improve cognitive performance and functional outcomes in patients with MCI and early AD.
Detailed description
Objectives There are currently no disease-modifying treatments for cognitive and behavioral symptoms associated with early clinical Alzheimer's disease (AD), and only minimally effective symptomatic treatments are available. In this application, we propose a transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention will target cognition and brain circuits that are impaired in patients with mild cognitive impairment (MCI) and early AD. The goal is to improve cognitive performance and functional outcomes in patients with MCI and early AD.
Research Plan and Methods This study will recruit 50 Veterans with MCI or very early AD who are receiving outpatient services at the Minneapolis VA Health Care System (MVAHCS) Geriatric Research, Education, and Clinical Center (GRECC) Memory Loss Clinic. This study will be a double-blind, randomized, placebo (sham) controlled study. Participants will be randomly assigned to receive either active or sham tDCS, both paired with cognitive training tasks. Ten sessions of training/tDCS sessions (20 minutes of 2mA current stimulation with 45 minutes of cognitive training tasks) will occur over 2-3 weeks, performed at the participant's home. Participants will attend an in-person enrollment and training session prior to study intervention. Follow-up sessions will occur via phone or video conference at 3 and 6 months after study initiation.
Clinical Relevance Executive cognitive impairments in patients with MCI or early AD have been associated with poor decision-making ability and lack of insight, potentially leading to compromised job performance, financial mismanagement, increased personal safety risk, relationship stress, and poor medical treatment adherence. While disproportionate memory impairment is a hallmark of both conditions, there are compensatory strategies available to reduce disability associated with very early stage memory impairment in those who are otherwise cognitively intact. Compensatory strategies are much less effective for executive dysfunction, as the disability itself impairs one's ability to recognize when such strategies are needed and successfully employ them. Novel, well-tolerated, neuroplasticity-based interventions that can reduce executive impairment by targeting both cognitive control (an executive ability) and its underlying neural dysfunction are needed to improve cognitive outcomes, safety, and quality of life for patients with MCI or early AD. Knowledge gained from this study can inform the future development of clinical treatment approaches aimed at reducing risk and delaying out-of-home placement in Veterans with cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active Transcranial Direct Current Stimulation (tDCS)Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes). |
| Sham tDCS | Sham comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS)Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This ramp up/down method is done at the end of the stimulation period, as well. This method mimics the physical sensation of stimulation typically encountered at the very beginning and end of the intervention period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- are a Veteran receiving services from the MVAHCS GRECC clinic
- have a clinical diagnosis of AD, MCI, or Mild Neurocognitive Disorder presenting as early AD type (predominantly amnestic and dysexecutive)
- are age 60 or older
- are stable on any medications for at least 1 month at the baseline visit
- demonstrate capacity to provide informed consent
Key exclusion criteria (5 listed)
- any significant medical disorder based on the Principal Investigator's judgment that would impact risk
- other psychiatric or neurological conditions that impact cognition
- metallic cranial plates/screws or implanted devices above the clavicle
- eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation
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 |
|---|---|---|
| Active Transcranial Direct Current Stimulation (tDCS)Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes. | Device | Active tDCS |
| Sham Transcranial Direct Current Stimulation (tDCS)Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session). | Device | Sham tDCS |
Primary outcome
Change in Brief Test of Adult Cognition by Telephone (BTACT)
Time frame: Change between baseline and 3 week follow-up; 3 and 6 months following study baseline
Differences in magnitude of change in BTACT scores between active tDCS and sham groups from baseline to follow-up sessions. BTACT covers five cognitive domains: episodic verbal memory (list learning), working memory span (digits backwards), executive functioning (verbal fluency), inductive reasoning (number series completion), and processing speed (backwards counting). Higher total score on the BTACT indicates better cognitive performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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 R McCarten, MD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Alzheimer Disease and Mild Cognitive Impairment, run by Minneapolis Veterans Affairs Medical Center 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John R McCarten, MD (612-467-3314, Riley.McCarten@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Test of Adult Cognition by Telephone (BTACT) (time frame: Change between baseline and 3 week follow-up; 3 and 6 months following study baseline). 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 14 Mar 2023.