Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (NCT03205709) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment
United States107 participantsStarted 2017-11-29
Plain-language summary
The purpose of this study is to evaluate if systematic cognitive training can improve cognitive performance in participants (55 and older) with memory loss. This study will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term changes in brain networks over an 18-month period. Although there is no distribution of medication for this study, participants are required to have an at-home computer.
Who can participate
Age range55 Years – 95 Years
SexALL
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Inclusion criteria
✓. Males and females 55 to 95 years of age (inclusive) at the time of informed consent.
✓. Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language.
✓. Meets criteria for cognitive impairment defined as scores \> 1 below standardized norms on memory function as identified by the Wechsler Memory Scale (WMS) III Logical Memory immediate or delayed recall score.
✓. Folstein Mini Mental State score ≥ 23 out of 30.
✓. A family member or other individual who is in contact with the patient and consents to serve as informant during the study; this can be a telephone informant in the case of patients who do not have a live-in informant or close significant other.
✓. Access to a home desktop or laptop computer at acceptable internet speed for the study duration.
Exclusion criteria
✕. Diagnosis of dementia of any type.
✕. Current clinical evidence of schizophrenia, schizoaffective disorder, major depression, psychosis, or bipolar I disorder (DSM-IV criteria).
✕. Active suicidal ideation or plan.
✕. Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 criteria).
✕. Clinical stroke with residual neurological deficits. While we will not exclude patients with cerebrovascular disease, we will not include patients who have had a stroke with residual clinical deficits because it is not clear that this type of patient is similar to the MCI (Mild Cognitive Impairment) patient generally, and clear-cut neurological impairment, e.g., hemiplegia/hemiparesis or speech impairment, may compromise the patient's ability to do the CCT or active control procedures and to complete the neuropsychological test battery.
What they're measuring
1
Change in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
✕. 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. Other patients receive medications that may be associated with cognitive impairment but are rarely considered the likely etiology, e.g., theophylline, nifedipine, beta blockers; they will not be excluded. Patients receiving other psychotropic medications not expected to have a material impact on cognition, e.g., SSRIs (Selective Serotonin Re-uptake Inhibitors) and SNRIs (Serotonin-norepinephrine re-uptake inhibitors) will be eligible.
✕. Presence of any of the following disorders: a) Central Nervous System infection, with cerebrospinal fluid evidence of meningitis, encephalitis, or other infectious process; b) dementia of any type; c) Huntington's disease; d) Multiple sclerosis; e) Parkinson's disease; f) Other neurologic disorders with focal signs, e.g., amyotrophic lateral sclerosis; g) Mental retardation.
✕. Acute, severe unstable medical illness. For cancer, acutely ill patients (including those with metastases) will be excluded, but past history of successfully treated cancer will not result in exclusion.