BridgeMD
New treatment option for Mild Cognitive Impairment
Official title Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT07243600
What this study is testing
- What it's testing
- This study is a validation study to evaluate efficacy of two neuroplasticity-based, computerized cognitive training programs to improve neurological and neuropsychological health in older adults with mild cognitive impairment (MCI).
- 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 65 and older
You may be able to join if
- Potential participant must be 65 years or older at the time of study screening.
- Potential participant must have MCI as defined by:
- Total score between 18-26 inclusive on the Montreal Cognitive Assessment (MoCA)
- Cognitive concern by participant, informant, or clinician and evidence of preserved functional abilities as defined as a Clinical Dementia Rating...
- Potential participant must have a study partner/informant defined as any acquaintance (e.g., family member, friend, neighbor, clinician) who has...
You likely can't join if
- Potential participant has an existing diagnosis of major neurocognitive disorder at screening (DSM-IV).
- Potential participant who answered 'yes' to question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS or 'yes' to any of the...
- Potential participant scores \>10 on the Geriatric Depression Scale - Short Form (GDS-SF).
- Potential participant has previously completed 10 or more hours of the computerized cognitive intervention program manufactured by Posit Science.
- Potential participant is participating in a concurrent clinical trial (involving an investigational pharmaceutical, behavioral treatment, medical...
- Potential participant is pregnant or breastfeeding.
See the full eligibility criteria
Who can join
- Potential participant must be 65 years or older at the time of study screening.
- Potential participant must have MCI as defined by:
- Total score between 18-26 inclusive on the Montreal Cognitive Assessment (MoCA)
- Cognitive concern by participant, informant, or clinician and evidence of preserved functional abilities as defined as a Clinical Dementia Rating (CDR) of 0.5 with a memory score of 0.5 or 1.
- Potential participant must have a study partner/informant defined as any acquaintance (e.g., family member, friend, neighbor, clinician) who has regular (at least monthly) interactions (in person or remote) with the...
- If potential participant reports use of medications typically prescribed for dementia such as, but not limited to, Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, Reminyl...
- Potential participant must demonstrate adequate decisional capacity, in the judgment of the investigator, and capable of to making an informed decision regarding their participation in this research study.
- Potential participant must be likely able to complete all study activities and outcome measures in the judgment of the investigator.
- Potential participant must have the visual, auditory, and motors capacity to use the computerized intervention in the judgment of the investigator.
- Potential participant must be able to communicate in either English or French.
What rules you out
- Potential participant has an existing diagnosis of major neurocognitive disorder at screening (DSM-IV).
- Potential participant who answered 'yes' to question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS or 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt...
- Potential participant scores \>10 on the Geriatric Depression Scale - Short Form (GDS-SF).
- Potential participant has previously completed 10 or more hours of the computerized cognitive intervention program manufactured by Posit Science.
- Potential participant is participating in a concurrent clinical trial (involving an investigational pharmaceutical, behavioral treatment, medical device or other) that, in the judgment of the investigator, could affect...
- Potential participant is pregnant or breastfeeding.
- Potential participant has claustrophobia or implantation with any medical devices above the waist that may concentrate radio frequency fields or have other medical issues that may frustrate participation in MRI/PET...
- Potential participant has a history of large vessel stroke with significant residual motor or cognitive impairment.
- Potential participant has a history of moderate to severe traumatic brain injury with residual cognitive symptoms.
- Potential participant has a history of brain tumor.
- Potential participant has a congestive heart failure diagnosis.
- Potential participant has a primary diagnosis of idiopathic Parkinson's disease.
- Potential participant has multiple sclerosis or Amyotrophic lateral sclerosis diagnosis.
- Potential participant has evidence of a non-neurodegenerative neurological disorder that would interfere with the ability to carry out study activities.
- Potential participant has has evidence of any other unstable medical conditions that would interfere with the ability to carry out study activities or cause fluctuations in cognition (for example, but not limited to...
- Potential participant has any other clinically significant or unstable medical condition (for example, but not limited to, ongoing alcohol dependency or drug abuse, schizophrenia, psychosis) that in the investigator's...
- Potential participant is undergoing or plans to undergo surgery requiring anesthesia, chemotherapy, or radiation treatment in the six months following screening (can be rescreened and enrolled later).
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
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, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. 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.