Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) Clinical Trial

Official title:

A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212692
• Other study ID #: NA_00039100
• Secondary ID: R01AG034934
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2010
• Last updated: December 8, 2015
• Start date: October 2010
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 100 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment
• Mild Cognitive Impairment (MCI)

Intervention

Behavioral:
• mentally stimulating activities
The study will compare the effects of different methods of mental stimulation. The intervention involves 6 classroom-style educational sessions and 10 mental stimulation studies involving computerized memory tasks.

Locations

Country	Name	City	State
United States	BPRU, Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Ordered Pointing Task		baseline	No
Primary	Trail-Making		baseline	No
Primary	Timed Instrumental Activities of Daily Living		baseline	No
Primary	Rey Auditory Verbal Learning Test		baseline	No
Primary	Self-ordered pointing task		immediately after the intervention	No
Primary	Self-ordered pointing task		3 months post intervention	No
Primary	Self-ordered pointing task		9 months post-intervention	No
Primary	Trail-Making		immediately after the intervention	No
Primary	Trail-Making		3 months post-intervention	No
Primary	Trail-Making		9 months post-intervention	No
Primary	Timed Instrumental Activities of Daily Living		immediately after the intervention	No
Primary	Timed Instrumental Activities of Daily Living		3 months post-intervention	No
Primary	Timed Instrumental Activities of Daily Living		9 months post-intervention	No
Primary	Rey Auditory Verbal Learning Test		immediately after the intevention	No
Primary	Rey Auditory Verbal Learning Test		3 months post-intervention	No
Primary	Rey Auditory Verbal Learning Test		9 months post-intervention	No
Secondary	Clinical Dementia Rating Scale		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Digit Symbol Substitution Test		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Digit Span		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Verbal Fluency Test		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Geriatric Depression Scale		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Neuropsychiatric Inventory		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Recollection Task		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	N-Back		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Rivermead Behavioral Memory Test		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Instrumental Activities of Daily Living		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Functional Capacities for Activities of Daily Living		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No
Secondary	Multifactorial Memory Questionnaire		baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention	No