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 |
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 |
QR Code |
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 |
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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, LCSWPhone: 858-822-4800
Email: participate@ucsd.edu