CLINICAL TRIAL

Happy Older Latinos are Active (HOLA) for Cognitive Decline

Recruiting · 18+ · All Sexes · Miami, FL

This study is evaluating whether a specific medication may help prevent cognitive decline in individuals living with HIV.

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About the trial for Cognitive Decline

Eligible Conditions
Cognitive Decline · Cognitive Dysfunction

Treatment Groups

This trial involves 2 different treatments. Happy Older Latinos Are Active (HOLA) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Happy Older Latinos are Active (HOLA)
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
are Latino (self-identified);
are age 50+;
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 16 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 16 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Happy Older Latinos are Active (HOLA) will improve 1 primary outcome and 9 secondary outcomes in patients with Cognitive Decline. Measurement will happen over the course of Baseline, 16 weeks.

Changes in biomarkers of cognition
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 anxiety as measured by the GAD-7
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.
Changes in neurocognitive impairment as measured by the Trails Making Test
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.
Changes in adiponectin
BASELINE, 16 WEEKS
Adiponectin will be assessed from blood samples.
Changes in psychosocial functioning as measured by the MSPSS
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.
Changes in neurocognitive impairment as measured by the WAIS-IV Digit Span
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. The scores are summarized with lower scores indicating increased cognitive impairment.
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Who is running the study

Principal Investigator
D. E. J.
Prof. Daniel Enrique Jimenez, Associate Professor
University of Miami

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes cognitive decline?

The majority of elderly patients showed no deficit on the cognitive screening test; thus, it was concluded that it was unlikely that the cognitive decline was related to age in this sample. It was thought that the cognitive decline may be attributable to the presence of multiple disabling health conditions in the majority of participants.

Anonymous Patient Answer

What are common treatments for cognitive decline?

There is no cure for dementia and treatments are focused on managing symptoms. Medication, in particular antipsychotics, are commonly prescribed to treatment resistant illnesses. In the USA, there is a high prevalence of Medicare patients receiving multiple prescription drugs; the most commonly prescribed are antipsychotics. What are common treatments for dementia? answer: Antipsychotics are the most commonly prescribed medication for dementia. Antipsychotics may be appropriate during the initial stages of DLD to ease anxiety and depression as well as for reducing agitation. Other medications frequently prescribed to dementia include antidepressants and sedating hypnotics. There is no consensus on the preferred pharmacological treatment for DLD.

Anonymous Patient Answer

Can cognitive decline be cured?

Because the underlying causes of cognitive impairment are so frequent and enduring in the population, current treatments that ameliorate their negative side-effects cannot be regarded as a curative therapy for cognitive decline and dementia as yet.

Anonymous Patient Answer

How many people get cognitive decline a year in the United States?

around 6% of people in the United States will have at least one mild cognitive impairment in the next 5 years, which will be the equivalent of 20 million people. Those with less education, less functional ability or higher comorbidity risks will be at higher risk.

Anonymous Patient Answer

What is cognitive decline?

Cognitive disability, as indicated by delayed cognition and slowed cognitive processes, is common, and is likely to worsen over time. It may also have significant clinical relevance: early identification and diagnosis can help delay or help prevent decline and is a potential target for interventions.

Anonymous Patient Answer

What are the signs of cognitive decline?

Some clinical signs are common and clinically significant such as difficulty in verbal tasks, perceptual difficulties, confusion, decreased ability to make judgements and poor attention span. Other signs include decreased attention, delayed responses, slowness of processing, decreased ability to plan and think ahead. Older adults are particularly at risk of having these clinically significant signs.

Anonymous Patient Answer

Have there been any new discoveries for treating cognitive decline?

There is accumulating evidence for pharmacological treatment that will soon become available for treating cognitive decline. Older people are also more likely to receive treatment, particularly those reporting mental health problems. Although these are compelling reasons to begin clinical trials, there is some evidence that they may be less effective than anticipated. If they do not work as well as hoped, some people with cognitive decline will likely opt not to participate (see Risk assessment and decision making).

Anonymous Patient Answer

Has happy older latinos are active (hola) proven to be more effective than a placebo?

The current evidence suggests that an optimistic attitude is associated with greater engagement in physical activity. Further investigation is needed to determine if positive outlook is correlated to more physically fit older adults.

Anonymous Patient Answer

How does happy older latinos are active (hola) work?

Hola Latinos have a lower frequency and intensity of physical activity compared with other latino older adults residing in Miami, Florida. Further study is needed to determine why physical activity levels are markedly different.

Anonymous Patient Answer

How serious can cognitive decline be?

The seriousness of cognitive deficits with age is difficult to measure but it should be considered in the evaluation of older patients with subjective complaints of memory loss or cognitive problems. Anemia and dehydration in older patients are also potentially serious but often treatable situations.

Anonymous Patient Answer

Does cognitive decline run in families?

Using data from the Cognitive Function Follow-Up Study of the National Institute of Mental Health, a large community sample, this study demonstrates that a paternal-but-no-maternal relationship between cognitive performance and parental longevity does indeed occur.

Anonymous Patient Answer

What are the latest developments in happy older latinos are active (hola) for therapeutic use?

As a therapeutic treatment for depression, for example, the addition of antidepressant drugs has been shown to be a good adjunct to psychotherapy on cognitive impairment in older Latino populations. Also, the use of these drug agents to treat depression has been demonstrated for the treatment of Alzheimer's disease even though there is no known therapeutic treatment for it.

Anonymous Patient Answer
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