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New treatment option for Age-related Cognitive Decline
Official title The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
ClinicalTrials.gov ID: NCT04171323
What this study is testing
- What it's testing
- Older adults at risk for dementia show a variety of cognitive deficits, which can be ameliorated by different cognitive training (CT) exercises. The best combination of CT exercises is unknown.
- 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 89
You may be able to join if
- 55 to 89 years of age
- Montreal Cognitive Assessment Score of 18-27 inclusive
- History of some change in cognitive function relative to established baseline and either 1) a CDR of 0.5; or 2) CDR of 0 and a clinical diagnosis of...
- If reports use of medications typically prescribed for dementia such as Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon...
- Adequate auditory capacity to understand normal speech. No greater than moderate hearing loss evident by thresholds less than or equal to 50 dB at...
You likely can't join if
- Currently enrolled in another assigned by chance clinical trial, treatment trial, or another research study that assesses cognition
- Dementia diagnosis
- Clinical Dementia Rating Scale of 1 or greater
- History of large vessel stroke with significant residual motor or cognitive impairment
- History of moderate to severe traumatic brain injury with residual cognitive symptoms
- History of brain tumor
See the full eligibility criteria
- 55 to 89 years of age
- Montreal Cognitive Assessment Score of 18-27 inclusive
- History of some change in cognitive function relative to established baseline and either 1) a CDR of 0.5; or 2) CDR of 0 and a clinical diagnosis of mild cognitive impairment (MCI) based on a multidisciplinary...
- If reports use of medications typically prescribed for dementia such as Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, or Reminyl, dose has been stable for at least 30 days
- Adequate auditory capacity to understand normal speech. No greater than moderate hearing loss evident by thresholds less than or equal to 50 dB at 1000 and 2000 Hz in at least one ear determined by an audioscope.
- Adequate visual capacity to read from a computer screen at a normal viewing distance as measured by binocular visual acuity of 20/50 or better tested with a standard near visual acuity chart
- Reports and shows adequate motor capacity to touch a computer screen or control a computer mouse.
- Wiling to complete all study activities
- Willing and capable of providing informed consent
- Ability to understand study procedures and comply with them for the length of the study
- Currently enrolled in another assigned by chance clinical trial, treatment trial, or another research study that assesses cognition
- Dementia diagnosis
- Clinical Dementia Rating Scale of 1 or greater
- History of large vessel stroke with significant residual motor or cognitive impairment
- History of moderate to severe traumatic brain injury with residual cognitive symptoms
- History of brain tumor
- Undergoing or plans to undergo surgery requiring anesthesia, chemotherapy, or radiation treatment in the six months following screening
- Congestive heart failure diagnosis
- Primary diagnosis of idiopathic Parkinson's disease
- Multiple sclerosis or Amyotrophic lateral sclerosis (ALS) diagnosis
- Evidence of a non-neurodegenerative neurological disorder that would interfere with the ability to carry out study activities.
- Evidence of any other unstable medical conditions that would interfere with the ability to carry out study activities or cause fluctuations in cognition (e.g., unstable diabetes, chronic obstructive pulmonary disorder...
- Geriatric Depression short scale score \>5/15. Participants with mood disorders that are treated and stable and have a GDS score \< 6/15 are not excluded.
- Any other clinically significant or unstable medical condition (e.g., ongoing alcohol dependency or drug abuse, schizophrenia, psychosis) that in the assessor's opinion would interfere with the ability to carry out...
- Previous participation in 10 or more hours of a computerized cognitive intervention program in the past two years
- Previous participation in cognitive intervention research at the study site in the past 2 years
- Planning on going away or being otherwise unavailable for a period of more than three weeks in the six months following screening
- Contraindications to MRI such as pacemaker, metal implants in body, or claustrophobia
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Gainesville, Florida, United States
- Tampa, Florida, United States
- Minneapolis, Minnesota, United States
- Greenville, South Carolina, United States
- Seneca, South Carolina, 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 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Gainesville, Florida, United States; Tampa, Florida, United States; Minneapolis, Minnesota, United States; Greenville, South Carolina, United States; Seneca, South Carolina, 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.