50 and older, any sex, with Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Completing the StudyPrimary· 16 weeks
Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.
Group
Value
95% CI
HOLA Group
90
Changes in Neurocognitive Impairment as Measured by the Trails Making TestSecondary· Baseline, 16 weeks
Trail Making Test (TMT). Time to accurately complete Part A and Part B. The TMT measures neurocognitive functioning and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment measured in seconds.
Trail Making Test (TMT) A-Baseline
Group
Value
95% CI
HOLA Group
48.7
± 24.0
Trail Making Test (TMT) B-Baseline
Group
Value
95% CI
HOLA Group
172.0
± 79.0
Trail Making Test (TMT) A-16 weeks
Group
Value
95% CI
HOLA Group
44.3
± 19.0
Trail Making Test (TMT) B-16 weeks
Group
Value
95% CI
HOLA Group
137.0
± 70.6
Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit SpanSecondary· Baseline, 16 weeks
The Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) asks participants to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. Each correct response earns 1 point, and the total raw score is converted to a scaled score ranging from 1 to 19. Higher scores indicate better cognitive performance; lower scores reflect increased neurocognitive impairment.
Baseline
Group
Value
95% CI
HOLA Group
6.5
± 1.93
16 weeks
Group
Value
95% CI
HOLA Group
6.81
± 2.34
Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ)Secondary· Baseline, 16 weeks
The Global Physical Activity Questionnaire (GPAQ) scoring is based on the amount of time a person spends being physically active in a typical week. It looks at three areas: activity at work or during daily tasks (including heavy lifting, digging, carrying loads, or light activities like cleaning); traveling from place to place (like walking or cycling); and recreational activities (such as exercise, sports, or active hobbies). Each activity is converted into a standard unit called MET-minutes (Metabolic Equivalent of Task). This allows different types of activity to be compared on the same sca
Baseline
Group
Value
95% CI
HOLA Group
1,743
± 2,842
16 weeks
Group
Value
95% CI
HOLA Group
4,533
± 5,008
Changes in Depression as Measured by the PHQ-9Secondary· Baseline, 16 weeks
The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that measures depression severity. The total score ranges from 0-27 with higher scores indicating more severe depression.
Baseline
Group
Value
95% CI
HOLA Group
6.67
± 4.84
16 weeks
Group
Value
95% CI
HOLA Group
4.26
± 3.35
Changes in Anxiety as Measured by the GAD-7Secondary· Baseline, 16 weeks
The Generalized Anxiety Disorder (GAD-7) is a 7 item questionnaire that measures anxiety severity. The total score ranges from 0-21 with higher scores indicating more severe anxiety.
Baseline
Group
Value
95% CI
HOLA Group
4.83
± 3.97
16 weeks
Group
Value
95% CI
HOLA Group
3.56
± 2.81
Changes in Psychosocial Functioning as Measured by the MSPSSSecondary· Baseline, 16 weeks
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item questionnaire that measures perceived social support. The total score ranges from 1-84 with higher scores indicating more perceived social support.
Multidimensional Scale of Perceived Social Support (MSPSS) baseline
Group
Value
95% CI
HOLA Group
5
± 1.2
Multidimensional Scale of Perceived Social Support (MSPSS) 16 weeks
Group
Value
95% CI
HOLA Group
5
± 1.2
Changes in Biomarkers of CognitionSecondary· Baseline, 16 weeks
Biomarkers of cognition including interleukin-15, brain derived neurotrophic factor (BDNF), and vascular endothelial growth factor (VEG-F) reported in pg/ml will be assessed from blood samples.
Changes in Biomarkers of Cognition LevelsSecondary· Baseline, 16 weeks
Biomarkers of cognition levels including irisin and insulin like growth factor (IGF-1) reported in ng/ml will be assessed from blood samples.
irisin Baseline
Group
Value
95% CI
HOLA Group
39.9
± 36.1
irisin 16 weeks
Group
Value
95% CI
HOLA Group
36.6
± 30.8
insulin like growth factor (IGF-1) baseline
Group
Value
95% CI
HOLA Group
79.4
± 51.1
insulin like growth factor (IGF-1) 16 weeks
Group
Value
95% CI
HOLA Group
65.8
± 34.3
Changes in AdiponectinSecondary· Baseline, 16 weeks
Adiponectin will be assessed from blood samples measured by ng/ml
Baseline
Group
Value
95% CI
HOLA Group
13999.1
± 3571.6
16 weeks
Group
Value
95% CI
HOLA Group
14289.6
± 3946.8
Sponsor's own description
The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· NA
· recruiting
NCT07394504 — Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy
· NA
· recruiting
NCT07127965 — Exercise Adherence and Cognitive Decline: Phase 2
· NA
· recruiting
NCT07151365 — Plant-based Diets and Healthy Aging
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 20 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04791709.