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Behavioural Intervention

Neurostimulation for Mild Cognitive Impairment (PAS-MCI Trial)

N/A

Recruiting

Led By Sanjeev Kumar, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of MCI due to AD using the core clinical criteria by the National Institute on Aging and Alzheimer's Association for MCI participants and ascertained by a study investigator.

Age 60 years or above

Must not have

Current use of an acetylcholine esterase inhibitor or memantine

Major Depressive Disorder with active symptoms in the last 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Summary

This trial is testing a neurostimulation approach to see if it can enhance prefrontal cortical plasticity and function in patients with MCI, in an effort to find a treatment modality that could potentially prevent progression to AD.

Who is the study for?

This trial is for right-handed individuals aged 60 or above with Mild Cognitive Impairment (MCI) due to Alzheimer's, who can communicate in English and have a MoCA score over 26. They should not be demented, nor have cognitive decline from vascular, traumatic, or medical causes. Participants must not use certain psychotropic medications or high doses of benzodiazepines and cannot have contraindications to MRI or TMS.

What is being tested?

The study tests Paired Associative Stimulation (PAS), a neurostimulation technique aimed at enhancing the plasticity of the prefrontal cortex in patients with MCI. The goal is to improve brain function and potentially prevent progression to Alzheimer's dementia by strengthening compensatory mechanisms.

What are the potential side effects?

While specific side effects are not listed here, PAS generally may cause discomfort at the stimulation site, headache, lightheadedness, or temporary changes in brain activity patterns which could affect cognition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with mild cognitive impairment due to Alzheimer's.

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I am 60 years old or older.

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I am currently taking medication for a brain or nerve condition.

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I am 60 years old or older.

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I have been diagnosed with mild cognitive impairment due to Alzheimer's.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for memory problems.

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I have been experiencing symptoms of major depression in the last 3 months.

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I am currently taking medication for seizures.

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I use more than the equivalent of 2 mg/day of lorazepam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately and 1 and 4 weeks following the 10-session course

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately and 1 and 4 weeks following the 10-session course

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately and 1 and 4 weeks following the 10-session course for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in N-Back Performance

Change in PAS-Long-term-potentiation (PAS-LTP)

N-Back Performance

+1 more

Secondary study objectives

Change in Executive Function Composite Measure

Executive Function Composite Measure

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Healthy ControlActive Control1 Intervention

Healthy Controls will complete screening and baseline N-Back and PAS-EEG. 10 HC participants will also complete the optional pilot eye tracking VPC assessment following N-Back at the Baseline visit. HC participants will not complete the 10-session course of PAS or follow-up assessments.

Group II: Active PASActive Control1 Intervention

After completing the N-back and PAS-EEG at Visit 4, MCI participants randomized to the active condition will receive a 10-session course of PAS (Visits 5-14), followed by the three follow-up assessments at 0 days, 7 days, and 28 days post intervention.

Group III: PAS-Control (PAS-C)Placebo Group1 Intervention

After completing the N-back and PAS-EEG at Visit 4, MCI participants randomized to the sham condition will receive a 10-session course of PAS-C (Visits 5-14), followed by the three follow-up assessments at 0 days, 7 days, and 28 days post intervention.

0 / 9Eligibility criteria met