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New treatment option for Mild Cognitive Impairment (MCI)
Official title Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 Trial
ClinicalTrials.gov ID: NCT06601933
What this study is testing
- What it's testing
- Effective, clinically meaningful treatments are lacking for patients with mild cognitive impairment (MCI), which is associated with increased risk of transition to dementia. Cognitive training represents an important therapeutic strategy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 week
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 89
You may be able to join if
- Access to a home desktop or laptop computer or tablet at acceptable internet speed for the study duration.
- Participants need to be 55 to 89 years of age (inclusive) at the time of informed consent.
- Females need to be post-menopausal (last period more than 12 months earlier by history).
- Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language.
- Meets criteria for cognitive impairment (CI), including either EMCI (early MCI) or LMCI (late MCI), defined as memory impairment documented by...
You likely can't join if
- Diagnosis of dementia of any type.
- Current clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis, or bipolar I disorder (Diagnostic and Statistical Manual of Mental...
- Current unstable or untreated major depression, or active suicidality based on a Suicide Severity Rating Scale (C-SSRS Screen version: positive...
- Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 TR criteria).
- Clinical stroke with residual neurological deficits. While we will not exclude participants with cerebrovascular disease or transient ischemic...
- Use of medications known to have a negative impact on cognition: benzodiazepines in lorazepam equivalents greater than or equal to 1 mg daily...
See the full eligibility criteria
- Access to a home desktop or laptop computer or tablet at acceptable internet speed for the study duration.
- Participants need to be 55 to 89 years of age (inclusive) at the time of informed consent.
- Females need to be post-menopausal (last period more than 12 months earlier by history).
- Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language.
- Meets criteria for cognitive impairment (CI), including either EMCI (early MCI) or LMCI (late MCI), defined as memory impairment documented by scoring below the education adjusted cutoff on the Logical Memory II...
- Montreal Cognitive Assessment (MoCA) score ≥ 20/30.
- An informant (relative, friend, other caregiver) who contacts the participant at least weekly is required to provide information about the participant's functioning. This can be a telephone informant in the case of...
- Must be English-speaking: Wide Range Achievement Test (WRAT3) score must indicate at least a 6th grade reading level with a score of ≥ 37.
- Diagnosis of dementia of any type.
- Current clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis, or bipolar I disorder (Diagnostic and Statistical Manual of Mental Disorders (DSM-5 TR) criteria).
- Current unstable or untreated major depression, or active suicidality based on a Suicide Severity Rating Scale (C-SSRS Screen version: positive answer to question 1 or 2 followed by item 6 positive answer leads to...
- Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 TR criteria).
- Clinical stroke with residual neurological deficits. While we will not exclude participants with cerebrovascular disease or transient ischemic attacks (TIAs), we do not wish to include participants with a frank clinical...
- Use of medications known to have a negative impact on cognition: benzodiazepines in lorazepam equivalents greater than or equal to 1 mg daily, narcotics, anticholinergics (ACB Calculator level 3 medication leads to...
- Presence of any of the following disorders: a) Central Nervous System Infections, with cerebrospinal fluid evidence of meningitis, encephalitis, or other infectious process; b) dementia of any type; c) Huntington's...
- Acute, severe unstable medical illness in the judgment of the clinician. For cancer, acutely ill participants (including those with metastases) are excluded, but history of successfully treated cancer does not result in...
- Contraindication to MRI scan: MRI incompatible pacemakers and metal implants, any other contraindication to MRI. For participants with possible claustrophobia, they must be willing to do the MRI with adjunct lorazepam...
- Regular use of crosswords or formal computerized cognitive training platforms averaging once per week or more than once per week in the past year. Eligible participants who join the trial are instructed not to do these...
- Participation concurrently in another therapeutic clinical trial of a cognitive enhancing drug or device or procedure.
- Geriatric Depression Scale (Short Form) score of ≥ 6.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 week per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; New York, New York, United States; Durham, North Carolina, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.