Enhancing Memory in Mild Cognitive Impairment and Early Stage Alzheimer's Disease

NCT ID: NCT05077826

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2023-04-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Full Current tES

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.

Group Type: EXPERIMENTAL

North Coast Medical Activadose II

Intervention Type: DEVICE

tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.

Partial Current tES

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.

Group Type: PLACEBO_COMPARATOR

North Coast Medical Activadose II

Intervention Type: DEVICE

tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.

Interventions

North Coast Medical Activadose II

tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 50-90 years of age, as verified via photo identification with date of birth.

2. Should be right-handed and learned English by seven years old.

3. Generally healthy

1. 50-90 years of age, as verified via photo identification with date of birth.

2. Should be right-handed and learned English by seven years old.

3. Is legally able to sign the consent form on their own behalf, or has a legally authorized representative that is able to sign.

4. Has a caregiver that can assist with taking health history.

Exclusion Criteria

1. Significant history of psychiatric disorders or current psychosis including self-report or Geriatric Depression Scale short form score-GDS >5 if uncertain.

2. Current excessive drug, alcohol or nicotine use defined by participant self-report.

3. History of epilepsy, migraines, severe stroke, or traumatic brain injury.

4. Taking medications with significant psychotropic effects.

5. Severe sensory impairment.

6. 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.

7. Severe subjective cognitive concerns.

8. Requires a helper animal.

9. Has sufficient prior experience with neurostimulation that might unblind or alter the results.

10. 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.

11. Has sensitivity to components of tES electrodes being used (typically nickel or latex).

12. 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.

1. Significant history of psychiatric disorders or current psychosis not related to a neurodegenerative condition.

2. Current excessive drug, alcohol or nicotine use.

3. Significant history of epilepsy, stroke, or traumatic brain injury.

4. Taking medications with significant psychotropic effects, not related to neurodegenerative condition

5. Severe sensory impairment

6. 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.

7. Requires a helper animal.

8. Has sufficient prior experience with neurostimulation that might unblind or alter the results.

9. Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation.

10. Has sensitivity to components of tES electrodes being used (typically nickel or latex).

11. 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Mind Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Clark, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

Mind Research Network

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

21-203

Identifier Type: -

Identifier Source: org_study_id