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New treatment option for Amnestic Mild Cognitive Impairment
Official title Training Response Artificial Intelligence Network (TRAIN)
ClinicalTrials.gov ID: NCT05903573
What this study is testing
- What it's testing
- This study will train a machine learning tool to predict response to a cognitive training intervention using baseline brain MRI sequences from older adults with amnestic mild cognitive impairment.
- Which group you join is 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 100
You may be able to join if
- Evidence of changed cognition reported by a close informant as obtained by an interview with a licensed clinical psychologist (PI, Gullett)
- Cognitive performance on one or more standardized neuropsychological measures of verbal or non-verbal memory \> 1.0 standard deviation or more below...
- No evidence of reported dependence in instrumental functional abilities (IADLs) despite reported cognitive difficulties
- No evidence of dementia based on cognitive screening (Montreal Cognitive Assessment Score within normal limits for age, education, and sex using the...
- Global clinical dementia rating scale (CDR) score must be equal to 0.5
You likely can't join if
- Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
- English as a second language
- Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics...
- Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g., Parkinson disease...
- Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled...
- Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive...
See the full eligibility criteria
- Evidence of changed cognition reported by a close informant as obtained by an interview with a licensed clinical psychologist (PI, Gullett)
- Cognitive performance on one or more standardized neuropsychological measures of verbal or non-verbal memory \> 1.0 standard deviation or more below the normative mean for age and education
- No evidence of reported dependence in instrumental functional abilities (IADLs) despite reported cognitive difficulties
- No evidence of dementia based on cognitive screening (Montreal Cognitive Assessment Score within normal limits for age, education, and sex using the NACC Uniform Data Set (UDS) norms.
- Global clinical dementia rating scale (CDR) score must be equal to 0.5
- Willingness to be assigned by chance into either the educational training (control) or intervention (cognitive training) group
- Able and willing to devote 12 weeks to the intervention with additional time for pre- and post-testing
- Able and willing to perform cognitive and emotional measures both on paper and on a tablet computer
- In line with the recommendations of the SCD task force, an informant must be available. This is to a) obtain information about the participant's complaints and cognitive difficulties on interview, and b) to ascertain...
- Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
- English as a second language
- Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal
- Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g., Parkinson disease, multiple sclerosis, seizure disorder, brain surgery, moderate TBI, REM...
- Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension, severe cardiac disease, etc.). No current cancer diagnosis
- Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the...
- Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
- Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention.
- Previous participation in a cognitive training study within the last 6 months or current involvement in another study involving cognitive, physical or other intervention at the time of participation.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, 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.