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 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.

VIVA MIND

Study Name	VIVA MIND
Description	The goal of this study is to advance a first-in-class, new small molecule treatment for early Alzheimer's disease (AD). Varoglutamstat (PQ912) is an oral, twice daily medication that addresses a novel and significantly differentiated amyloid target: N-terminal post-translationally modified Ab (pGlu-Ab), a particularly toxic subspecies of amyloid beta (Ab). This study will further evaluate whether varoglutamstat's mechanism of action can result in a measurable therapeutic effect on cognition, function and relevant pharmacodynamic and biological markers in early AD.
Required Diagnosis	Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) or mild probable AD
Age	50 - 89 (inclusive)
Length	Phase 2A: Minimum of 24 wks Phase 2B: 72 wks of tx
Lumbar Puncture	Required - 1 at screening, 2 during the treatment period
MRI	Required if the participant has not had an MRI scan within 6 months of screening
Amyloid PET	No
Tau PET	No
Compensation	Yes
Contact	clinicaltrialsadrc@health.ucsd.edu
More Information	NIH Clinical Trials Website

Avanir

Study Name	Avanir/ASPECT Study
Required Diagnosis	Probable Alzheimer's disease and clinically significant, moderate-to-severe agitation for at least 2 wks prior to Screening that interferes with daily routine
Age	50 - 90 (inclusive)
Length	Approx. 20 wks (up to 28-day screening period, 12-wk treatment period, and 30-day follow-up period)
Lumbar Puncture	No
MRI	No
Amyloid PET	No
Tau PET	No
Compensation	Yes
Contact	clinicaltrialsadrc@health.ucsd.edu
For More Information	Study Flyer (PDF)

Alnylam

Studies	Alnylam
Study Description	The goal of this study is to evaluate the safety and tolerabiulity of intrathecal doses of an investigational agent designed to lower the level of amyloid precursor protein messenger RNA, in hope of fulfilling the unmet need for treatment that can slow, halt, or potentially reverse the pathologic cascade common to early onset Alzheimer's disease.
Main Requirements	Age 18 or older, amyloid positive, EOAD
Required Diagnosis	MCI or mild dementia due to EOAD (disease onset at age < 65 years), AD dx confimed by CSF biomarkers or positive PET amyloid
Age	18 and older
Length	Part A: Up to 14 months Part B: Up to 26 months
Lumbar Puncture	10+
MRI	Required
Amyloid PET	Required
Tau PET	Optional
Compensation	Yes
Contact	clinicaltrialsadrc@health.ucsd.edu

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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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.

For more information contact:

Tracey Truscott, LCSW
Phone: 858-822-4800
Email: participate@ucsd.edu