Alzheimer DiseaseMEMORINCT05077826
Enhancing Memory in Mild Cognitive Impairment and Early Stage Alzheimer's Disease
A study testing North Coast Medical Activadose II in people with Alzheimer Disease and Mild Cognitive Impairment, run by The Mind Research Network at 1 site in United States.
Trial summary
The investigators have developed a low-risk transcranial Electrical Stimulation (tES) treatment that has improved learning and performance in young adults up to nearly 4 times when compared with a sham control. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- North Coast Medical Activadose II
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 30 Apr 2023
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-90 years of age, as verified via photo identification with date of birth.
- Should be right-handed and learned English by seven years old.
- Generally healthy
- 50-90 years of age, as verified via photo identification with date of birth.
- Should be right-handed and learned English by seven years old.
- Is legally able to sign the consent form on their own behalf, or has a legally authorized representative that is able to sign.
- Has a caregiver that can assist with taking health history.
Who cannot join
- Significant history of psychiatric disorders or current psychosis including self-report or Geriatric Depression Scale short form score-GDS >5 if uncertain.
- Current excessive drug, alcohol or nicotine use defined by participant self-report.
- History of epilepsy, migraines, severe stroke, or traumatic brain injury.
- Taking medications with significant psychotropic effects.
- Severe sensory impairment.
- Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
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- Severe subjective cognitive concerns.
- Requires a helper animal.
- Has sufficient prior experience with neurostimulation that might unblind or alter the results.
- Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation or be an MRI contraindication, or has any other MRI contraindication.
- Has sensitivity to components of tES electrodes being used (typically nickel or latex).
- Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, recent or unusual (for them) loss of taste or smell, congestion or runny nose, nausea or diarrhea.
- Significant history of psychiatric disorders or current psychosis not related to a neurodegenerative condition.
- Current excessive drug, alcohol or nicotine use.
- Significant history of epilepsy, stroke, or traumatic brain injury.
- Taking medications with significant psychotropic effects, not related to neurodegenerative condition
- Severe sensory impairment
- Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
- Requires a helper animal.
- Has sufficient prior experience with neurostimulation that might unblind or alter the results.
- Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation.
- Has sensitivity to components of tES electrodes being used (typically nickel or latex).
- Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, unusual loss of taste or smell, or unusual (for them) congestion or runny nose, nausea or diarrhea.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mind Research Network
Albuquerque, New Mexico, 87106
About this study
Official title: Modern Energetic Methods of Response Improvement (MEMORI)
The investigators have developed a low-risk transcranial Electrical Stimulation (tES) treatment that has improved learning and performance in young adults up to nearly 4 times when compared with a sham control. This randomized pilot trial will determine if this same tES protocol improves memory in older adults (50-90 years old) who are healthy, and separately in older adults with mild cognitive impairment (MCI) or early stage Alzheimer's disease (AD). TES will be applied to the right temple and left arm for up to 40 minutes. MRI images, along with other measures, may be obtained before and after tES. If effective, this intervention may help to improve the quality of life for AD patients and their families.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- North Coast Medical Activadose II
- Keywords
- Dementia, Memory, Transcranial direct current stimulation (tDCS), Magnetic resonance imaging (MRI)
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
North Coast Medical Activadose IIDevice
tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.
| Study group | Role | What they receive |
|---|---|---|
| Full Current tES | Experimental | TES delivered with the anode over the right temple and cathode on the left arm, at an intensity of up to 4 milliamps, delivered for up to 40 minutes. Receives: Device: North Coast Medical Activadose II |
| Partial Current tES | Placebo comparator | TES delivered with the anode over the right temple and cathode on the left arm, at an intensity of 0.1 milliamp, delivered for up to 40 minutes. Receives: Device: North Coast Medical Activadose II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning Task Performance
Performance accuracy on a complex visual learning and categorization task after full-current tES in comparison to partial-current tES.
Measured: Within one hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start7 Oct 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Clark, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077826
- Sponsor's protocol ID
- 21-203
- Acronym
- MEMORI
- Status last verified
- Mar 2024
- First submitted
- 7 Sep 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modern Energetic Methods of Response Improvement (MEMORI)
- ClinicalTrials.gov ID
- NCT05077826
- Acronym / sponsor ID
- MEMORI / 21-203
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Dementia, Memory, Transcranial direct current stimulation (tDCS), Magnetic resonance imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 14 Oct 2021 (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.
The investigators have developed a low-risk transcranial Electrical Stimulation (tES) treatment that has improved learning and performance in young adults up to nearly 4 times when compared with a sham control. This randomized pilot trial will determine if this same tES protocol improves memory in older adults (50-90 years old) who are healthy, and separately in older adults with mild cognitive impairment (MCI) or early stage Alzheimer's disease (AD). TES will be applied to the right temple and left arm for up to 40 minutes. MRI images, along with other measures, may be obtained before and after tES. If effective, this intervention may help to improve the quality of life for AD patients and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Current tES | Experimental | Device: North Coast Medical Activadose IITES delivered with the anode over the right temple and cathode on the left arm, at an intensity of up to 4 milliamps, delivered for up to 40 minutes. |
| Partial Current tES | Placebo comparator | Device: North Coast Medical Activadose IITES delivered with the anode over the right temple and cathode on the left arm, at an intensity of 0.1 milliamp, delivered for up to 40 minutes. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50-90 years of age, as verified via photo identification with date of birth.
- Should be right-handed and learned English by seven years old.
- Generally healthy
- 50-90 years of age, as verified via photo identification with date of birth.
- Should be right-handed and learned English by seven years old.
Key exclusion criteria (23 listed)
- Significant history of psychiatric disorders or current psychosis including self-report or Geriatric Depression Scale short form score-GDS >5 if uncertain.
- Current excessive drug, alcohol or nicotine use defined by participant self-report.
- History of epilepsy, migraines, severe stroke, or traumatic brain injury.
- Taking medications with significant psychotropic effects.
- Severe sensory impairment.
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 |
|---|---|---|
| North Coast Medical Activadose IItES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES. | Device | Full Current tES, Partial Current tES |
Primary outcome
Learning Task Performance
Time frame: Within one hour after treatment
Performance accuracy on a complex visual learning and categorization task after full-current tES in comparison to partial-current tES.
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 13 Mar 2024.
- 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.
Vincent Clark, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing North Coast Medical Activadose II in people with Alzheimer Disease and Mild Cognitive Impairment, run by The Mind Research Network 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 7 inclusion and 23 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 13 Mar 2024. 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?
Learning Task Performance (time frame: Within one hour after treatment). 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 13 Mar 2024.