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Cognitive Training

Phase 2

Aging | Unknown | Other |Elevance Health, Inc.|Last Updated: Apr 16, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment2,832

FDA Designations

No designations recorded

Clinical trial landscape

Cognitive Training · 1 trial · 2 indications

Phase 2 1
NCT00298558ACTIVE: Advanced Cognitive Training for Independent and Vital ElderlyAging
COMPLETED2,832 Analytics
PHASE2COMPLETED
ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly
AgingUnlock trial analytics

Study Endpoints

Primary Endpoints

Changes in Cognitive Abilities of Memory From Baseline to Year 10
Up to 10 years

Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

Changes in Cognitive Abilities of Reasoning From Baseline to Year 10
Up to 10 years

Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10
Up to 10 years

Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10
Up to 10 years

The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

Changes in Everyday Problem Solving From Baseline to Year 10
Up to 10 years

Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

Changes in Everyday Speed of Processing From Baseline to Year 10
Up to 10 years

Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

Secondary Endpoints

Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use
10th Year
Examine Health, Genetic and Cognitive Moderators
10th Year
Estimate the Effects of ACTIVE Training to General Population
10th Year
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Memory TrainingACTIVE_COMPARATORMemory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
Reasoning TrainingACTIVE_COMPARATORReasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
Speed of Processing TrainingACTIVE_COMPARATORSpeed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
ControlPLACEBO_COMPARATORThis group did not complete any cognitive training interventions

Interventions

NameTypeDescription
Cognitive TrainingBEHAVIORALMemory, Reasoning, or Speed of Processing cognitive training interventions
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites7

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 ...

Countries:United States
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Competitive Landscape -Cardiac Imaging 3 trials (matched to "Aging")

Frequently asked questions about Cognitive Training

What is Cognitive Training used for in aging?

Cognitive Training is an investigational intervention being studied for use in aging and healthy elderly populations. It is designed to address cognitive function in older adults, with the goal of supporting independent and vital living. The intervention is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Cognitive Training?

Cognitive Training is being developed by Elevance Health, Inc., a company publicly traded under the ticker symbol ELV. The company is conducting clinical research to evaluate the intervention's effects on cognitive function in older adults. Elevance Health is responsible for the ongoing development and clinical testing of this investigational product.

What phase is Cognitive Training in?

Cognitive Training is currently in Phase 2 clinical development. It is an investigational intervention and has not yet received regulatory approval. The Phase 2 trial has been completed, and the intervention is being studied for its potential effects on cognitive function in aging populations. Further development stages have not been publicly disclosed.

What clinical trials is Cognitive Training in?

Cognitive Training has one completed clinical trial, identified as NCT00298558, titled "ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly." This Phase 2 trial enrolled 2,832 participants aged 65 years and older in the United States. The study was placebo-controlled and randomized, though it was not double-blinded.

Is Cognitive Training the same as ACTIVE?

Cognitive Training is associated with the clinical trial known as ACTIVE, which stands for Advanced Cognitive Training for Independent and Vital Elderly. The trial, identified as NCT00298558, evaluated the intervention in healthy older adults. This trial is the primary clinical study associated with Cognitive Training in aging populations.