Brief Summary

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Official Title: "Phase 1 Study of Cognitive Activation Behavioral Therapy for MCI: A Randomized Waitlist-Control and Delayed Active-Control Study"

Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually among older adults, in which a person notices a decline in attention or memory, and performs worse than normal on cognitive tests of such. People with MCI are more likely to develop Alzheimer's disease or related dementia than others their same age, and so MCI is thought of as an early warning sign of progressive cognitive decline.

While some forms of MCI may be brought about by purely genetic causes, other cases may be due to a withdrawal of cognitive engagement with the world. In these cases, a rigorous program of cognitive training may be beneficial, halting or reversing symptom progression.

The current study will evaluate a multifaceted cognitive activation program on older adults with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a total of 100 hours of training. Training consists of meditation exercises for broad attention activation, Tai Chi exercises to integrate cognition with body awareness, and cognitive training through computerized attention, memory, and problem solving exercise.

Subjective impressions and objective measures of cognitive ability will be measured before and after the intervention. The investigators will also examine effects on mood and levels of daily function. Results will be compared to a waitlisted control group. The control group will subsequently be entered into a home-based version of the program for 10 weeks, with assessment before and after training, to look at the importance of the group meeting dynamic in promoting cognitive change.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: March 2013

Interventions Used in this Clinical Trial

• Behavioral: Cogntive Activation Training
  • Mindfulness-based stress reduction - 30 minutes / class x 3 classes / week; optional home practice Tai Chi - 30 minutes / class x 3 classes / week; optional home practice Computer-based cognitive training - 20 minutes / class x 3 classes / week; optional home practice
• Behavioral: Waitlist Control / Home-based training
  • Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Waitlist Control / Home-based training
  • This group will serve as a waitlist control group while the active group is performing training. Following assessment at the end of the active group period, this group will begin home-based training and will be assessed at the end of that 10 week period.
• Experimental: Cognitive Activation Group
  • This group will attend the 3/week group intervention meetings over 10 weeks.

Outcome Measures for this Clinical Trial

Primary Measures

• Processing Speed
  • Time Frame: Before and After Intervention
    Safety Issue?: No
• Memory
  • Time Frame: Before and After Intervention
    Safety Issue?: No
• Executive Function
  • Time Frame: Before and After Intervention
    Safety Issue?: No
• Attention / Working Memory
  • Time Frame: Before and after intervention
    Safety Issue?: No

Secondary Measures

• Mood and Well-being
  • Time Frame: Before and after intervention
    Safety Issue?: No
• Daily Function
  • Time Frame: Before and after intervention
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Subjective complaint about decline in memory or attention
• > 1 deviation below age-norm performance on memory or attention tasks
• Independence in daily living
• English speaking

Exclusion Criteria

• Neurological disorders (including aphasias) or reversible causes of dementia (e.g., hypothyroidism or B12 deficiency)
• Montreal Cognitive Assessment (MOCA) score < 24
• Clinical mood disorder such as depression or anxiety
• Other serious medical conditions that preclude participation in the program

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Rotman Research Institute at Baycrest
• Collaborator
  • Roy Hintsa
• Provider of Information About this Clinical Study
  • Principal Investigator: Norman Farb, Postdoctoral Fellow - Rotman Research Institute at Baycrest