The PACE study: a randomized clinical trial of cognitive activity strategy training for older people with mild cognitive impairment

Abstract

Objective: The role of cognition-focused interventions in reducing cognitive decline in older people remains uncertain. This study aimed to clarify whether a group cognitive activity (CA) strategy-training program would decrease the 2-year rate of cognitive decline of people with mild cognitive impairment (MCI).

Design: Randomized controlled trial.

Setting: One study site.

Participants: 160 older adults with MCI ≥65 years of age (mean: 75, SD: 5.8).

Intervention: Five-week CA strategy training or a control nonspecific educational program. The primary outcome measure was change from baseline in the total score on the Cambridge Cognitive Examination-Revised (CAMCOG-R). Secondary outcomes of interest included changes in memory, attention, executive functions, mood, and quality of life. Endpoints were collected 10, 52, and 104 weeks post baseline.

Results: Intention to treat analysis identified no significant difference in CAMCOG-R scores over time between the two groups (mean difference: -0.36, 95% CI: -1.02,0.29) or across secondary outcome measures. The exceptions were better performance of the CA group on immediate attention (Digit Span Forwards, adjusted mean difference: 0.15, 95% CI: 0.01,0.30) and better quality of life (adjusted mean difference: 0.57, 95% CI: 0.10,1.04) compared with controls.

Conclusion: The devised program of CA did not improve general cognitive performance of older adults with MCI over a period of 2 years. Although favorable, the beneficial effects of the intervention on attention and quality of life were small, and of uncertain significance.

Keywords: Neuropsychology; cognition; dementia; intervention; prevention.