An interventional study of Aerobic & Cognitive Training (ACT) and Cycling Only in Mild Cognitive Impairment, sponsored by Arizona State University. Completed at 4 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by Arizona State University · Not applicable, Interventional, and Treatment
Among 1,418 studies in Cognitive Dysfunction with a site in United States — 328 open to participants now, 432 under way, 13 of them phase 3. Cognitive Dysfunction · United States.
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, this one is the 258th largest by enrollment of the 1,143 interventional ones that give a count, is one of 84 that started in 2018, is one of 713 with no phase, and was the 514th registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
Browse Cognitive Dysfunction studies →328 of the 1,418 studies in Cognitive Dysfunction with a site in United States are open now. Recruiting first, the newest first:
National Institute of Mental Health (NIMH) · Sites in United States
Prevention Research Consortium Corp. · Sites in United States
University of California, San Francisco · Sites in United States
The University of Texas Medical Branch, Galveston · Sites in United States
Medical University of South Carolina · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,418 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 125 · Phase 2 233 · Phase 3 54 · Phase 4 58
First in 1993; this study’s year is marked. 84 started in 2018.
This study's enrollment of 146 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 58 across the 1,143 interventional studies, 150 across the 270 observational. Of the 885 that completed or were terminated, 377 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
209 of 1,418 have an industry lead sponsor. The 10 most frequent:
Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
Arizona State University has 7 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
176 of the studies in Cognitive Dysfunction with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT06191965Phase 3Mclean HospitalMitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction | 2027-01-31 |
| NCT06950190Phase 3Ellis MedicineEvaluating Cognitive Changes on Patients in Chemotherapy (ECCPC) | 2027-02-20 |
| NCT03560960Boston UniversityMulti-Center Development of a Novel Diagnostic Test for Alzheimer's Disease | 2026-11 |
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This multi-site clinical trial occurs at the University of Minnesota and University of Rochester. It tests the efficacy and additive/synergistic effects of an ACT intervention on cognition and relevant mechanisms (aerobic fitness, Alzheimer's disease [AD] signature cortical thickness, and default mode network [DMN]) in older adults with amnestic MCI (aMCI).
Because almost all drug trials for Alzheimer's disease (AD) have failed, developing non-pharmacological interventions with strong potential to prevent or delay the onset of AD in high-risk populations (e.g., those with mild cognitive impairment [MCI]) is critically important. Aerobic exercise and cognitive training are 2 promising interventions for preventing AD. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective neural function intensively. Hence, combined Aerobic exercise and Cognitive Training (ACT) may very well have an additive or synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested ACT's effects, and those studies have reported discrepant findings, largely due to varying ACT programs. The purpose of this single-blinded, 2×2 factorial Phase II randomized controlled trial (RCT) is to test the efficacy and additive/synergistic effects of a 6-month combined cycling and speed of processing (SOP) training intervention on cognition and relevant mechanisms (aerobic fitness, AD signature cortical thickness, and functional connectivity in the default mode network [DMN]) in older adults with amnestic MCI (aMCI).
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Moderate-intensity cycling, 3 times a week for 6 months, supervised by an exercise specialist
Behavioral: Cycling Only
Computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
Behavioral: Cognitive Training Only
Moderate-intensity cycling followed by computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
Behavioral: Aerobic & Cognitive Training (ACT)
Stretching and mental stimulation activities, 3 times a week for 6 months, supervised by a specialist
Behavioral: Stretching and Mental Stimulating Activities
ACT stands for combined aerobic exercise and cognitive training.
Cycling on a recumbent stationary cycle
Engage in cognitive training on a computer
Stretching exercises and mental stimulating activities on a computer
Executive function
EXAMINER
Time frame: Change from baseline to 3, 6, 12, and 18 months
Episodic memory
RAVLT and BVMTR
Time frame: Change from baseline to 3, 6, 12, and 18 months
AD-signature cortical thickness
Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 6, 12, and 18 months
Functional connectivity in DMN
Functional MRI for Default Mode Network
Time frame: Change from baseline to 6, 12, and 18 months
Aerobic fitness
VO2peak from symptom-limited peak cycle-ergometer test, and 10-m Incremental Shuttle Walk Test
Time frame: Change from baseline to 3, 6, 12, and 18 months
Conversion to Alzheimer's disease
Clinical adjudication of Alzheimer's disease dementia
Time frame: Change from baseline to 6, 12, and 18 months
Plan to share: No
Ran from Jul 2018 to primary completion in Jul 2024, 72 months.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 72 months is above that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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