Clinical trial NCT01212692: Effects of Mental Stimulation in Patients With Mild Cognitive Impairment
Official title: A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Cognitive Impairment (MCI)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-10-01
Enrollment: 63
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn if activities that challenge the brain (mentally stimulating activities) can improve memory and other types of thinking in patients with Mild Cognitive Impairment. The study will compare the effects of different methods of mental stimulation.


Eligibility criteria: Inclusion Criteria:

* ≥ 50 years of age
* meet criteria for amnestic-Mild Cognitive Impairment (MCI)
* have capacity to give informed consent
* have capacity to complete assessment measures

Exclusion Criteria:

* history of drug or alcohol dependence
* severe psychiatric conditions associated with psychosis (e.g., schizophrenia)
* recent stroke
* clinical diagnosis of probable Alzheimer's Disease
* history of seizure disorder, serious head trauma, or other medical, psychiatric, or neurological conditions associated with significant cognitive impairment (e.g., Parkinson's Disease, Korsakoff's, HIV)
* current use of Alzheimer's Disease medications (e.g., cholinesterase inhibitors, memantine)

Primary outcomes:
measure: Self-Ordered Pointing Task
timeFrame: baseline
measure: Trail-Making
timeFrame: baseline
measure: Timed Instrumental Activities of Daily Living
timeFrame: baseline
measure: Rey Auditory Verbal Learning Test
timeFrame: baseline
measure: Self-ordered pointing task
timeFrame: immediately after the intervention
measure: Self-ordered pointing task
timeFrame: 3 months post intervention
measure: Self-ordered pointing task
timeFrame: 9 months post-intervention
measure: Trail-Making
timeFrame: immediately after the intervention
measure: Trail-Making
timeFrame: 3 months post-intervention
measure: Trail-Making
timeFrame: 9 months post-intervention
measure: Timed Instrumental Activities of Daily Living
timeFrame: immediately after the intervention
measure: Timed Instrumental Activities of Daily Living
timeFrame: 3 months post-intervention
measure: Timed Instrumental Activities of Daily Living
timeFrame: 9 months post-intervention
measure: Rey Auditory Verbal Learning Test
timeFrame: immediately after the intevention
measure: Rey Auditory Verbal Learning Test
timeFrame: 3 months post-intervention
measure: Rey Auditory Verbal Learning Test
timeFrame: 9 months post-intervention
Secondary outcomes:
measure: Clinical Dementia Rating Scale
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Digit Symbol Substitution Test
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Digit Span
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Verbal Fluency Test
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Geriatric Depression Scale
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Neuropsychiatric Inventory
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Recollection Task
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: N-Back
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Rivermead Behavioral Memory Test
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Instrumental Activities of Daily Living
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Functional Capacities for Activities of Daily Living
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
measure: Multifactorial Memory Questionnaire
timeFrame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: BPRU, Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Paul B Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: