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Intervention Studies (Clinical Trials)

About Clinical Trials

An interventional study, or clinical trial, is a research study in which a human subject is assigned to one or more interventions (which may include an investigational drug, placebo, or other control) to evaluate the effects of those interventions on health-related or behavioral outcomes. 


Clinical Trials for Persons with Normal Cognition, Mild Cognitive Impairment (MCI), Early Alzheimer's Disease, and Other Dementias

The ADRC Clinical Trials Unit has a variety of clinical trials available for participants with Alzheimer's disease and related dementias. We continue to add new studies to our portfolio regularly and encourage individuals who are interested in participating to reach out to our team at the ADRC.

See below for studies currently in the pipeline that will be starting recruitment in the near future or download the clinical trials flyer (PDF) for more information.

Brain Derived Neurotropic Factor

Study BDNF
Study Description This is an open label, Phase I, first-in-human clinical trial of AAV2-BDNF gene therapy for early Alzheimer’s Disease (AD) and Mild Cognitive Impairment (MCI). The primary aim is to determine whether administration of the nervous system growth factor “Brain-Derived Neurotrophic Factor” (BDNF) to eligible patients with AD and MCI is safe and tolerable. BDNF will be administered via gene therapy using a MRI guided stereotaxic approach which has shown to be safe and effective in animal studies. This study will be used to determine whether BDNF administration reduces neuronal loss and rebuilds synapses in the brain of patients with AD and MCI.
PI Gabriel Leger, M.D.
Main Requirements People who participate in this gene therapy study must have a confirmed diagnosis of early Alzheimer's disease and be otherwise healthy. The following requirements are necessary to be considered for enrollment in this research trial: 1) A neurologist-certified diagnosis of "Probable Alzheimer's Disease" or “Mild Cognitive Impairment”. 2) Early stage of the disease (generally within 2-4 years of diagnosis). 3) Completely normal speaking ability and completely normal ability to understand what others are saying. 4) An ability to understand the potential risks of participation in this study (described in more detail below). 5) Must be willing to stay in the San Diego area and be available for up to 10 visits in the first year.
Required Diagnosis MCI or probable mild AD
Age Minimum 50
Length 2 years
Lumbar Puncture 3 times
MRI Required
Amyloid PET Required
Tau PET No
Compensation No - travel cost reimbursement only
Contact jar040@health.ucsd.edu, clinicaltrialsadrc@health.ucsd.edu
For more information https://today.ucsd.edu/story/first-in-human-clinical-trial-to-assess-gene-therapy-for-alzheimers-disease

https://neurosciences.ucsd.edu/centers-programs/neural-repair/bdnf-gene-therapy-trial.html

Affiliated Research Groups

Virtual Reality Brain Health Study

Studies Virtual Reality Brain Health Study
Study Description The purpose of this study is to use a novel virtual reality (VR) based activity that simultaneously engages physical and cognitive activity aimed at improving brain health and cognition in older adults. We will compare 3 types of activities combined VR physical and cognitive, physical activity only, and VR cognitive activity only over 16 weeks to evaluate changes in brain health, cognition, blood-based biomarkers, and physical function in older adults.
PI Dr. Judy Pa
Main Requirements Between 50 and 85 years of age
Fluent in English
Can safely ride a stationary bike
Required Diagnosis No diagnosis required
Age 50-85 (inclusive)
Length Approx. 8-9 months including 4 months of active study participation and a follow-up visit 4 months later
Lumbar Puncture No
MRI 2 scans Required
Amyloid PET No
Tau PET No
Compensation Yes
Contact brainhealth@health.ucsd.edu
For more information

https://thepalab.com/participate/

Study Flyer (pdf)centers-programs/adrc/enrolling-studies/clinical-trials/Virtual-Reality-Brain-Health-Study-No-Stamp.pdf

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Mente Sana/Mind Boost

Studies

 Mente Sana/Mind Boost Study

Study Description

 Kaiser Permanente Washington and the University of California San Diego (UCSD) are doing research to learn about different programs to improve the brain health of Hispanic/Latino(a) adults ages 55 and over. We are testing two different programs done independently at home: one is focused on gradually increasing physical activity; the other will focus on learning about healthy lifestyle changes that can help improve brain health. Both programs will be given over 12 weeks. Regardless of which program you end up in, they both fit within your daily life and are personalized to your situation and all activities in the study will be remote and done at your home. We developed the programs to work for people with different levels of ability, fitness, and health conditions.

PI

 Zvinka Zlatar (UCSD) and Dori Rosenberg (Kaiser Permanente Washington)

Main Requirements

  • Self identifying as Hispanic/Latino(a)
  • Speak English or Spanish
  • Have a smartphone and access to the internet
  • Are able to walk one block without help
  • Reside in Southern California

Required Diagnosis

Cognitively healthy

Age

55 to 89

Length

~20 weeks (12 weeks of intervention + up to 8 weeks of baseline and post intervention measurement assessments). All done at home. No need to travel anywhere. 

Lumbar Puncture

No

MRI

No

Amyloid PET

No

Tau PET

No

Compensation

Up to $100 for completing all measurement visits and a Fitbit Inspire device

Contact

Rosa Gutierrez Aceves at 858-822-7737

For more information

contact us at 858-822-7737

Biomarkers Predictors of Memantine Sensitivity in Patients with AD

Study Name Biomarkers Predictors of Memantine Sensitivity in Patients with AD
Required Diagnosis ​Alzheimer's disease
Age 50 - 83
Length ​Six visits over a 30-week period
Medication All study participants receive active treatment with memantine, an FDA-approved medication for Alzheimer's Disease.
Lumbar Puncture No
MRI No
Amyloid PET No
Tau PET No
Compensation Eligible subjects will receive up to $390 for their time
Contact ​Joyce Sprock
619-471-9455
AlzheimersStudy@health.ucsd.edu
More Information

 

Biomarker Predictors of Memantine Sensitivity Flyer (PDF)

Research Registry

If you are interested in any of our current studies or you'd like to participate in a study but don't currently see one that is a match for you, join our research registry to be placed on a list for future studies.

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For more information contact:

Phone: 858-822-4800
Email: participate@ucsd.edu