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Interventional 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.

Alector AL001-3

Alector AL001-3 is a phase-3 study for individuals at risk for or with frontotemporal dementia due to mutations in the progranulin gene. This study will provide genetic testing for individuals with a family history who may be eligible to participate. The length of the trial ranges from 48 weeks to 96 depending on the treatment condition. 

MAIN REQUIREMENTS: Age 18-85; known carriers of heterozygous loss-of-function progranulin gene (GRN) mutations.

Study Name Alector AL001-3
Required Diagnosis Diagnosis of FTD and known carriers of heterozygous loss-of-function progranulin gene (GRN) mutations
Age ​18 - 85 (inclusive)
Length ​6 wks (screening) + 48 wks (symptomatic) or 96 wks (pre-symptomatic) of treatment period + 8 wks (safety follow-up)
Lumbar Puncture ​Optional (1 at screening and 2 during the treatment period)
MRI ​Required
Amyloid PET No
Tau PET No
Compensation Yes
Contact ​clinicaltrialsadrc@health.ucsd.edu
More Information Download the PDF

Janssen JNJ-63733657ALZ2002

Janssen JNJ-63733657ALZ2002 is a phase 2 study aiming to slow the progression of prodromal and mild Alzheimer’s disease by preventing the propagation of tauopathy. The length of the trial is up to 4.5 years.

MAIN REQUIREMENTS: Age 55-80; evidence of pathological tau on a screening PET scan.


Study Name ​Janssen JNJ-63733657ALZ2002
Required Diagnosis Diagnosis of ​prodromal/early Alzheimer's disease (AD)
Age ​55 - 80 (inclusive)
Length 90 days screening period +  treatment period of up to 4.5 years + safety follow-up 90 days after last dose
Lumbar Puncture Optional - 4 LPs (1 at screening and3 during treatment period)
MRI ​Required
Amyloid PET No
Tau PET Required
Compensation Yes
Contact ​clinicaltrialsadrc@health.ucsd.edu
More Information NIH Clinical Trials Website

Biogen 221AD304

​Phase-3 study targeting amyloid-beta in participants with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease. Please note that this is a re-dosing study that is only open to participants who were previously enrolled in the Aducanumab studies (221AD103, 221AD301, 221AD302, 221AD205).

Study Name ​​Biogen 221AD304
Required Diagnosis Alzheimer's disease
Age N/A
Length ​126 wks (8 wks screening, 100 wks treatment period, 18 wks safety followup after the last dose)e
Lumbar Puncture Optional - 3 LPs (1 at screening, 2 during the treatment period)
MRI ​Required
Amyloid PET Optional
Tau PET Optional
Compensation Yes
Contact ​clinicaltrialsadrc@health.ucsd.edu
More Information NIH Clinical Trials Website

Brain Derived Nerve Growth Factor

Study Name Brain Derived Nerve Growth Factor
Required Diagnosis Amnestic Mild Cognitive Impairment (aMCI) or probable mild Alzheimer's disease
Age Minimum 50
Length 2 years 12 (screening + baseline + pre-op + surgery + 8 follow up visits)
Lumbar Puncture Required - 3LPs (Baseline, 15 month, and 27 month)
MRI ​N/A - but CT or MRI within 24 months of screening will be looked at for inclusion criteria
Amyloid PET No
Tau PET No
Compensation Yes
Contact ​clinicaltrialsadrc@health.ucsd.edu
More Information

San Diego Union Tribune Article

VIVA MIND

Study Name VIVA MIND
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
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

Alzheon APOLLOE4 ALZ-801

Study Name Alzheon APOLLOE4 ALZ-801
Required Diagnosis ​Mild Cognitive Impairment or Mild Dementia due to Alzheimer's disease and carrier of the APOE E4/E4 genotype
Age 50 - 80 (inclusive)
Length ​Up to 11wks screening + treatment duration 78wks (18 mos) + 4 wks until safety follow up visit
Lumbar Puncture No
MRI Required (CT is acceptable with prior approval for those who can not undergo MRI)
Amyloid PET No
Tau PET No
Compensation Yes
Contact ​clinicaltrialsadrc@health.ucsd.edu
More Information

NIH Clinical Trials Website

Affiliated Research Groups

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)