Phase 3 N=2,832 Randomized Single-blind Prevention

ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly

Aging · Healthy

Bottom Line

View on ClinicalTrials.gov: NCT00298558 ↗

Enrolled (actual)

2,832

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: Changes in Cognitive Abilities of Memory From Baseline to Year 10 — -10.6; -11.2; -12.7; -9.4 units on a scale — p=0.43

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Cognitive Training (Behavioral)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Carelon Research
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Cognitive Abilities of Memory From Baseline to Year 10	-10.6; -11.2; -12.7; -9.4	0.43
PRIMARY Changes in Cognitive Abilities of Reasoning From Baseline to Year 10	-3.23; -0.049; -3.94; -3.04	0.69
PRIMARY Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10	-144.4; -126.2; 24.3; -123.3	0.45
PRIMARY Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10	-3.05; -2.66; -2.34; -3.61	<0.01 sig
PRIMARY Changes in Everyday Problem Solving From Baseline to Year 10	-6.10; -5.58; -5.98; -5.67	0.97
PRIMARY Changes in Everyday Speed of Processing From Baseline to Year 10	-1.53; -1.39; -1.47; -1.42	0.78
SECONDARY Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use	—	—
SECONDARY Examine Health, Genetic and Cognitive Moderators	—	—
SECONDARY Estimate the Effects of ACTIVE Training to General Population	—	—

Summary

The purpose of the ACTIVE study was to test if cognitive training interventions could maintain functional independence in elders by improving basic mental abilities, with follow-up assessments through five years.

Eligibility Criteria

Inclusion Criteria

Age 65 or older
Mini-Mental State Examination (MMSE) score 23 or greater
Vision scored greater than 20/50
Minimal dependence in hygiene, bathing, and dressing

Exclusion Criteria

Significant decline in cognitive skills, physical abilities, or functional independence
Inability to complete study activities as evidenced by MMSE and vision scores lower than Inclusion Criteria requirement
Diagnosis of Alzheimer's disease
Stroke in previous 12 months
Cancer with limited life expectance
Current chemotherapy or radiation treatment
Communication problems
Planned move from study area
Scheduling conflicts that would preclude participation in study activities
Prior involvement in similar cognitive training studies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00298558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.