Mild Cognitive Impairment Clinical Trial
— WATER-VetOfficial title:
Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial
This four-year study will evaluate the efficacy of an exercise training augmentation for cognitive training intervention to improve memory performance in Veterans with a diagnosis of amnestic Mild Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise phase and 2) a cognitive training program. The exercise phase will be an aquatic based exercise program. A combination of exercise and cognitive training programs designed for persons without cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy older adults, it is important to adapt these programs for persons beginning to exhibit clinically significant memory problems, such as those with aMCI.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | June 30, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility | Inclusion Criteria: - Veterans, aged 50 to 90, of any racial or ethnic group - Diagnosis of single or multi-domain amnestic MCI using criteria per National Institute on Aging/Alzheimer's Association Guidelines - Available informant for completion of the Clinical Dementia Rating Scale - Visual and auditory acuity to allow neuropsychological testing - Willingness to participate in clinical trial for 14 months (8-month treatment phase, 6-month no-contact follow-up phase) - Musculoskeletal illness or injury (i.e., osteoporosis, degenerative disc or joint disease, arthritis, obesity) - Approval by Primary Care Provider to participate in water-based physical exercise Exclusion Criteria: Psychiatric Exclusions - Current, uncontrolled severe psychiatric disorder, such as Bipolar I, Schizophrenia, or Major Depressive Disorder as determined by the Mini International Neuropsychiatric Interview (MINI) - Diagnosis of dementia, Clinical Dementia Rating Scale (CDR) > 0.5; modified Hachinksi score 4; or delirium. Those Veterans with scores indicative of dementia (CDR > 0.5, modified Hachinksi 4) will be referred to the Memory Disorders Clinic at VAPAHCS for a full diagnostic work-up Medical Exclusions - History of neurological (e.g., multiple sclerosis, seizure disorder, stroke,) or system illness affecting CNS function (e.g., liver failure, kidney failure, congestive heart failure, systemic cancer) - Acute illness or unstable chronic illness, e.g., history of severe liver disease (cirrhosis, esophageal varices, ascites, portal hypertension, hepatic encephalopathy) - Current severe cardiac disease (e.g., uncontrolled atrial fibrillation, defined as mean 24 hour heart rate >85 beats/min, or 24 hour maximal ventricular rate >150 beats/min; uncontrolled ventricular arrhythmias, defined as recurrent ventricular tachycardia >3 beats in succession, or 24 hour PVC count >20%; active pericarditis or myocarditis; Class III/IV heart failure and / or ejection fraction < 20%; thrombophlebitis; pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen; embolism within past 6 months) - Inability to participate in an exercise stress test - Inability to read, verbalize understanding and voluntarily sign the Informed Consent |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive Function Composite Score (ADAS-Cog-Exe) | The ADAS-Cog is a structured scale that evaluates multiple cognitive domains including: orientation, memory, reasoning, language, and praxis. | 8 months | |
Secondary | Peak VO2 | Peak VO2, or VO2Max, is defined as the minute volume of O2 utilization | 8 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04513106 -
Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial
|
N/A | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Active, not recruiting |
NCT03167840 -
Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment
|
N/A | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Not yet recruiting |
NCT05041790 -
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment
|
Phase 4 | |
Recruiting |
NCT04121156 -
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Completed |
NCT02774083 -
Cognitive Training Using Feuerstein Instrumental Enrichment
|
N/A | |
Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
Enrolling by invitation |
NCT06023446 -
Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
|
||
Completed |
NCT04567745 -
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
|
Phase 1 | |
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Terminated |
NCT02503501 -
Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease
|
Phase 2 | |
Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT02663531 -
Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Recruiting |
NCT03507192 -
Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
|
N/A |