Physical Activity, Alzheimer's Disease and Cognition Relative to APOE Genotype
NCT03876314, Not applicable, Completed, University of North Carolina, Greensboro
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Physical Activity, Alzheimer's Disease and Cognition Relative to APOE Genotype | ClinicalTrials.gov |
| NCT number | NCT03876314 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 180 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of North Carolina, Greensboro | ClinicalTrials.gov |
| Conditions | Healthy, Dementia, Alzheimer Disease, Physical Activity | ClinicalTrials.gov |
| Interventions | Physical Activity Condition | ClinicalTrials.gov |
| First posted | 2019-03-15 | ClinicalTrials.gov |
| Last updated | 2026-08-21 | ClinicalTrials.gov |
Registered outcomes 38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Performance on the Cognitive Domain of Executive Function as Measured With Stroop Interference Reaction Time (RT) | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in executive function will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on Stroop Interference. Stroop interference is calculated using reaction time (RT) data from correct trials and the following formula: Stroop Interference RT = Stroop Incongruent RT - (average (Stroop Congruent RT , Stroop Neutral RT)). Stroop Congruent is also known as Stroop Word, and Stroop Neutral is also known as Stroop Color. RT is recorded in msec and a larger score is indicative of greater interference (worse performance) | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Executive Function as Measured With Trail Making Test Interference | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in executive function will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the Comprehensive Trail Making Test (TMT) interference. TMT interference is calculated as total time to complete TMT B (also called Trail 5) minus the total time to complete TMT A (also called Trail 1)which were both recorded in seconds. TMT interference is, therefore, recorded in seconds with a larger score indicative of greater interference (worse performance) | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Executive Function as Measured With NIH Toolbox Dimensional Change Card Sort | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in executive function will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the NIH Toolbox Dimentional Change Card Sort Test (DCCS). We used the recommended outcome of the DCCS computed score. This is calculated automatically within the NIH Toolbox based upon a two-stage process combining a score of 0-5 from the accuracy data with a score of 0-5 from the reaction time data. Thus, scores range from 0-10 with a higher score indicative of better performance. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Executive Function as Measured With the NIH Toolbox Flanker Test. | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in executive function will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the NIH Toolbox Flanker Inhibitory Control and Attention Test. We used the recommended outcome of the Flanker computed score. This is calculated automatically within the NIH Toolbox based upon a two-stage process combining a score of 0-5 from the accuracy data with a score of 0-5 from the reaction time data. Thus, scores range from 0-10 with a higher score indicative of better performance. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Executive Function as Measured With Matrix Reasoning. | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in executive function will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on Matrix Reasoning Accuracy from the Virginia Cognitive Aging Project (VCAP). Version O was given at pre, Version A was given at mid, and Version B was given at post. Possible scores are proportions that range from 0-1 (i.e., 0% accuracy to 100% accuracy expressed on a 0.00-1.00 scale) with a higher score being indicative of better performance. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Memory as Measured With the Auditory Verbal Learning Test. | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in memory will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the Auditory Verbal Learning Test. Majdan et al. (1996) Form 1 was given at pre, the standard Rey Auditory Verbal Learning list was given at mid, and Majdan et al. (1996) Form 2 was given at post. These versions are comparable in terms of their scores (Sherman, Tan, \& Hrabok, 2022). Possible scores range from 0-15 with a bigger score being indicative of better memory. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Memory as Measured With the Rey-Osterrieth Complex Figure Test | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in memory will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the Rey Osterreith Complex Figure Test. Tests were scored using the deep learning approach for automated scoring published by Langer et al. eLife 2024;13:RP96017. DOI: https://doi.org/10.7554/eLife.96017. Possible scores range from 0-36 with higher scores being indicative of better memory. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Memory as Measured With the NIH Toolbox Picture Sequence Test | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in memory will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the NIH Toolbox Picture Sequence Memory Test - The computed score is an IRT-based theta score of the number of adjacent pairs placed for trial 1 and 2 with a higher score being indicative of better memory. This score is automatically created within the NIH Toolbox. Version A was given at pre, Version B was given at mid, and Version C was given at post. Possible scores range from 200-700 with a higher score being indicative of better performance. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Memory as Measured With the Mnemonic Similarity Test | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in memory will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) Lure Discimination Index (LDI) on the Mnemonic Similarity Test (MST). The MST was created based upon the publicly available and validated instructions and stimuli provided by the creators of the task (Stark, Kirwan, \& Stark, 2019). Equivalent versions of the test are administered so participants see different stimuli at each testing session and those stimuli were counterbalanced to rotate through the different item types. The formula for calculating the LDI is: p(similar\|lure) - p(similar\|foil) where p(similar\|lure) = Total # of "similar" responses to lure items / 36 and p(similar\|foil) = Total # "similar" responses to foil items / 36. Scores range from -1 to +1 with a larger score indicating better discrimination performance. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Attention as Measured With the Paced Auditory Serial Addition Test | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in attention will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the 2-sec trial of the Paced Auditory Serial Addition Task. Scores are reported as the number of correct responses with possible scores ranging from 0-60 and larger scores being indicative of better attention. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Attention as Measured With the Forward Digit Span Test | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in attention will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the Neurological Assessment Battery (NAB) Digit Span Forward test. Scores are reported as the number of correct trials with possible scores ranging from 0-14 and larger scores being indicative of better attention. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Working Memory as Measured With NIH Toolbox List Sort Working Memory | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in working memory will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the NIH Toolbox List Sort Working Memory Test. Scores are reported as the sum of the total number of items correctly recalled and sequenced on Lists 1 and 2 with possible scores ranging from 0-26 and larger scores being indicative of better working memory. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Working Memory as Measured With Spatial Working Memory | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in working memory will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) reaction time on the 4-dot trial of the Spatial Working Memory Test. Scores are reported as the average reaction time (RT) for correct responses. Smaller scores are indicative of faster performance (i.e., better performance). | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Working Memory as Measured With Backward Digit Span | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in working memory will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) accuracy on the Neurological Assessment Battery (NAB) Digit Span Backwards test. Scores are reported as the number of correct trial with possible scores ranging from 0-14 and larger scores being indicative of better working memory. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Digit Symbol Modalities Test (SDMT) | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in working memory will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the Digit Symbol Modalities Test (SDMT) (Smith, 1973). Scores are reported as the sum of Oral and Written Trial Raw Scores (correct responses) with possible scores ranging from 0-220 and larger scores being indicative of better working memory. | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Stroop Word Test | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in processing speed will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on Stroop Word condition (also known as the Stroop Congruent condition). RT is recorded in msec and a larger score is indicative of slower performance (worse performance) | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Stroop Color Test | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in processing speed will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on Stroop Color condition (also known as the Stroop Neutral condition). RT is recorded in msec and a larger score is indicative of slower performance (worse performance) | ClinicalTrials.gov |
| Primary | Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Trail Making Test A | Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) | Change in executive function will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) performance on the Comprehensive Trail Making Test (TMT) A (TMT A) (also known as Trail 1). Performance is recorded in seconds with a larger score indicative of slower performance (worse performance) | ClinicalTrials.gov |
| Secondary | Change in Brain Morphology (Whole Brain Volume) | Pre-Test and Post-Test (~12 months) | Change in whole brain morphology will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) for total segmented brain volume (i.e., total brain separated from non-brain structures). This is measured as volume (mm3), with volumes ranging from 1,050,000 to 1,350,000, and with higher values being interpreted as better. | ClinicalTrials.gov |
| Secondary | Change in Brain Morphology (Left Hippocampus Volume) | Pre-Test and Post-Test (~12 months) | Change in Left Hippocampus Volume will be assessed by comparing Pre-Test, Mid-Test (\~6 months), and Post-Test (\~12 months) for total segmented left hippocampus volume (i.e., left hippocampus segmented away from other regions). This is measured as volume (mm3), ranges from 2500 to 4500, and higher values are better. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AG058919 | The effect of physical activity on cognition relative to APOE genotype (PAAD-II) | ETNIER, JENNIFER L | UNIVERSITY OF NORTH CAROLINA GREENSBORO | NATIONAL INSTITUTE ON AGING | 2018 to 2022 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 13
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Dimensional Change Card Sort | Primary outcome | ConductCognition |
| Eriksen Flanker Task | Primary outcome | ConductCognition |
| Matrix Reasoning | Primary outcome | ConductCognition |
| Mnemonic Similarity Task | Primary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Picture Order Memory Test | Primary outcome | ConductCognition |
| Spatial Working Memory | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)