ClinicalTrials.gg
Status unknownNCT01641328FarbMCI2012Updated Jul 16, 2012

Cognitive Activation Therapy for MCI: A Randomized Control Study

A Phase 1 interventional study of Cogntive Activation Training and Waitlist Control / Home-based training in Mild Cognitive Impairment, sponsored by Rotman Research Institute at Baycrest. Status unknown at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-07-16.

Sponsored by Rotman Research Institute at Baycrest · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Mild Cognitive Impairment
  • MCI
  • Meditation
  • Mindfulness
  • Cognitive Activation
  • Cognitive Training
  • Tai Chi
03

In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's planned enrollment of 30 is below the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Rotman Research Institute at Baycrest is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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.

    Behavioral: Waitlist Control / Home-based training

  • Experimental
    Cognitive Activation Group

    This group will attend the 3/week group intervention meetings over 10 weeks.

    Behavioral: Cogntive Activation Training

Interventions

  • BehavioralCogntive 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

    Also known as: Computer-based cognitive training is provided by Lumosity

  • BehavioralWaitlist Control / Home-based training

    Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day

    Also known as: Computer-based cognitive training is provided by Lumosity, Biofeedback relaxation training is provided by HeartMath

06

What researchers measure

Primary outcomes

  1. Processing Speed

    Processing speed on computerized cognitive task.

    Time frame: Before and After Intervention

  2. Memory

    Tests of immediate recall and delayed recall, recognition, and familiarity.

    Time frame: Before and After Intervention

  3. Executive Function

    Tests of inhibition, task switching, and problem solving.

    Time frame: Before and After Intervention

  4. Attention / Working Memory

    Working memory measures such as digit span, selection of targets among distractors, etc.

    Time frame: Before and after intervention

Secondary outcomes

  1. Mood and Well-being

    Tests of dysphoric affect and subjective quality of life

    Time frame: Before and after intervention

  2. Daily Function

    Tests of instrumental activities of daily living

    Time frame: Before and after intervention

07

Study locations

1 site
  • Baycrest
    Toronto, Ontario M6A2E1, Canada
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01641328
Lead sponsor
Rotman Research Institute at Baycrest
Collaborators
Roy Hintsa
Responsible party
Norman Farb (Postdoctoral Fellow, Rotman Research Institute at Baycrest) — Principal investigator
First posted
Jul 16, 2012
Start date
Oct 2012
Primary completion
Mar 2013 (estimated)
Completion
Jul 2013 (estimated)
Last update
Jul 16, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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