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Clinical Trials

Clinical Trial Registry

Are you interested in clinical trials but don't currently see one that suits you? You can now join our ADRC Registry to be placed on a list for future studies. 

Participants can be normal controls, have a slight memory problem, or be diagnosed with early to moderate AD. 

*Call the ADRC 858-822-4800 and ask for Christina Gigliotti for more information.

Clinical Trials Currently Enrolling New Participants

Parkinson's Progression Markers Initiative
Biomarkers in Aging, MCI, and Alzheimer's Disease
Nerve Growth Factor
ADNI-GO - Click here to watch a video about participation in the study

For more information on each of these enrolling studies see below.

 

Parkinson's Progression Markers Initiative

PI: Douglas Galasko, M.D.

PPMI is a five-year observational study of PD and control participants. The study is designed to establish a comprehensive set of clinical, imaging and biosample data that will be used to define biomarkers of PD progression. Once these biomarkers are defined, they can be used in therapeutic studies, which is the ultimate goal.

PPMI will follow standardized data acquisition protocols to ensure that tests and assessments conducted at multiple sites can be pooled in centralized databases and repositories. The clinical, imaging and biologic data will be easily accessible to researchers in real time through a Web portal. The biological samples collected throughout the course of PPMI will be stored in a central repository that will be accessible to any scientist with promising biomarker leads for the purposes of verifying initial results and assessing correlations to clinical outcomes and other biomarkers. Only with collaborative efforts like PPMI can we efficiently identify and validate biomarker candidates for PD progression.

Who can take part in PPMI?

PPMI seeks to enroll participants from two groups: 200 controls who do not have PD and 400 Parkinson’s or “possible PD” patients (these can be patients who are newly diagnosed and have taken medication for less than 60 days or, ideally, patients who have not yet started taking PD medication; patients with possible PD are also highly qualified for the study). Participants must be at least 30 years of age. Volunteers will be enrolled in PPMI through summer 2012. Once enrolled, subjects will participate in the study through summer 2015, completing three to five years of study visits depending on their enrollment date.

A patient I recently diagnosed with PD has not yet begun medication, but may need to start soon. Can s/he still participate in PPMI?

Yes, and in fact, patients like these are the most appropriate subjects for the study. If possible, enrollees are asked to stay medication-free for the first six months of participation. For many newly diagnosed patients who take part in PPMI, it will become necessary to start PD medications at some point during the course of the study. Starting PD meds at any point after enrolling in PPMI does not compromise a patient’s eligibility to participate. Further, PPMI sites acknowledge that all treatment decisions are of primary importance and should be determined solely between the patient and his or her primary doctor.

What is the visit schedule for individuals who enroll in the study?

Participants will be required to make four study visits in their first year, with visits twice a year thereafter. Each visit will include different tests, assessments and biologics sampling, including motor, neuropsychiatric and cognitive assessments; DatSCAN and MRI imaging; and, blood, cerebrospinal fluid (CSF), urine and DNA sampling.

Click here for more information:

To participate contact:

Christina Gigliotti, Ph.D. or Deborah Fontaine, N.P. at 858-822-4800

 

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Biomarkers in Aging, MCI and AD

PI: Douglas Galasko, M.D.

This study will measure levels of a number of different proteins in cerebrospinal fluid (CSF) and in blood in order to compare these biomarker levels amongst people who have normal cognitive ability, mild memory problems, or early Alzheimer’s’ disease (AD).

Criteria

  • healthy adults, ages 65 – 90
  • individuals with MCI, ages 60 – 90
  • early stage AD, ages 60-90
  • no lower back problems
  • study partner
  • general good health

Study Procedures

  • 5 years duration:
  • 1, 1-2 day visits/year
  • Lumbar puncture (for CSF)
  • blood work
  • memory assessments
  • Click here to view a video of the LP procedure

Compensation

  • participants will receive $100 per year of the study for undergoing the lumbar punctures.
  • all study procedures provided at no cost

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Nerve Growth Factor

PI: Mike Rafii, MD, PhD.

Time Involved

24 Months

Description

Nerve Growth factor (NGF) research is a phase 2 double-blind placebo controlled study. The purpose is to test the safety, tolerability, and effectiveness of a new experimental gene transfer drug called Cere-110 in those with mild-to-moderate AD. Studies suggest that NGF may help increase the survival of neurons that degenerate in AD. The ability of NGF to prevent brain cell loss in animal models of AD has led to delivering NGF to humans. In this study NGF is delivered directly by surgical insertion into the region of the brain where cell death occurs. Gene therapy is experiemental and has not yet been approved by the FDA

Requirements

  • 55-80 years old
  • On stable AD medication for 3 months
  • Have a study partner for all visits
  • Fluent in English
  • Are in general good health

Click here for more information.

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ADNI-GO

PI: James Brewer, MD, PhD

Time Involved

This is a longitudinal study that will span 18 months with an extension.

Description:

Your participation in this research may help us learn how to stop the progression of mild cognitive impairment (MCI) and Alzheimer’s disease (AD) in future generations. The goal of this research study is to determine whether the imaging of the brain (through MRI, PET and amyloid imaging scans) can help predict and monitor the onset and progression of AD. In addition to neuroimaging, the study will collect and test blood and cerebral spinal fluid to determine if biomarkers can predict and monitor the disease.

Requirements:

  • Are between 55 and 90 years of age.
  • Are in good general health but have memory problems or concerns
  • Are fluent in English or Spanish- Are willing and able to undergo the test procedures
  • Have a study partner – a friend or relative who can accompany the volunteer to all clinic visits

Contacts:

Helen Vanderswag, RN (858) 822-4800

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