Research in Alzheimer's Disease

We are conducting clinical research studies for men and women who have probable memory disorders. Clinical research is necessary to learn whether investigational drugs work and are safe. The information gained from these trials could help future patients who need this type of medical care. 
 

A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (Generation S1)

Site Principal Investigator: Geoffrey Ahern, MD, PhD

[Study Sponsor: Novartis Pharmaceuticals]

The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.

Key Inclusion Criteria:

  • Consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype.
  • Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential.
  • Mini-Mental State Examination (MMSE) total score ≥ 24 (at screening or in previous 3 months) and cognitively unimpaired as evaluated by memory tests performed at screening.
  • Homozygous APOE4 genotype.
  • Participant's willingness to have a study partner.


For more information, please visit the Generation Program website: www.generationprogram.com

This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT02565511

A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (Generation S2)

Site Principal Investigator: Geoffrey Ahern, MD, PhD

[Study Sponsor: Novartis Pharmaceuticals]

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

Key Inclusion Criteria:

  • Consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid.
  • Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential
  • Cognitively unimpaired as evaluated by memory tests performed at screening.
  • Participant's willingness to have a study partner.
  • Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging).

For more information, please visit the Generation Program website: www.generationprogram.com

This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT03131453

Alzheimer's Disease Core Center & Arizona Alzheimer's Disease Consortium (ADCC)

[Funded by: National Institute on Aging]

An Alzheimer's Disease Core Center (ADCC) has recently been established in the state of Arizona under the aegis of the National Institute on Aging (NIA) — the Arizona Alzheimer's Disease Consortium. 

 

This effort has as its primary aim, the development of a clinical database that will help to further research in Alzheimer's Disease and other dementing illnesses.  While the ultimate goal is to find treatments and (ultimately) a cure for these diseases, the primary purpose of the ADCC will be to collect data on the clinical manifestations and course of these illnesses, and correlate these data with pathological examination of the brain. This is a multi-center collaborative effort that includes the Sun Health Research Institute, Barrow Neurological Institute, Mayo Clinic Scottsdale, and the University of Arizona Health Sciences Center. The primary investigators at UMC are Dr. Ahern and Dr. Rapcsak. 

 

Participation will require:

  • Screening of the (potential) subject by a neurologist at one of the participating institutions.  Pertinent laboratory tests will be reviewed.
  • If the subject meets entry criteria, they will be invited to enter the ADCC.
  • At the first visit, a small amount of blood and saliva will be drawn for various genetic studies.
  • Upon entry and each year thereafter, they will take pencil-and-paper tests to assess their condition.
  • At the time of their demise, the subject will have a brain-only autopsy performed by a neuropathologist at Sun Health Research Institute. 

​​Although such a requirement may seem drastic to some people, it cannot be emphasized enough that the only way to be absolutely sure of what the patient actually had is through the examination of brain tissue—without this information, a physician can only make an "educated guess" as to what the patient's true diagnosis was—such "guesses" are only correct 85-90% of the time, even in the best clinical centers.

The brain autopsy is also required of persons participating in the role of "normal controls" (see below).  The reason for this is that even "normal" folks can show changes in their brain as a function of aging and furthermore, may have had an "event" (such as a small stroke) that was clinically-inapparent during their lives.  It is absolutely essential that the researchers have this information, if they are to make valid conclusions regarding what separates a brain affected by a dementia versus a normal brain.

The NIA is sensitive to the fact that certain groups (e.g., Hispanic, Native American) may have cultural prohibitions against such a procedure—for them, the autopsy requirement can be waived, although we strongly encourage subjects from these groups to consider having the autopsy performed, as it may lead to important discoveries about how diseases such as Alzheimer's may differentially affect people of various races.

We invite interested parties to speak with one of the staff about entry into the ADCC.  This includes not only patients with dementing illnesses, but "normal" people as well.  Being screened, of course, does not guarantee entry in the Core, as multiple factors have to be considered. But if you are entered into the Core, you can rest assured that you will be making a valuable contribution to research aimed at eliminating these dreaded diseases from the face of the earth.  There are other benefits as well: 

First, your family and descendants will know exactly which disease you suffered from.  This may be of greater and greater importance in the near future, as discoveries derived from the analysis of the human genetic code allow medicine to develop specific cures for specific diseases.  It may also allow your descendants to know what neurological illnesses they are at risk for, which may have great importance if preventative strategies are found for certain diseases.

Second, all of these procedures (including the autopsy) are performed at no cost to you.

Third, you may be offered the opportunity to participate in clinical trials being carried out at the member institutions.  Such trials of potential therapies may come from the NIA, National Institutes of Health (NIH), Alzheimer's Disease Cooperative Study (ADCS)—a government-funded, multicenter-consortium of university centers involved in Alzheimer's research, or from the pharmaceutical industry.

 

If you are interested in participating in the ADCC, we encourage you to contact one of the staff at the Neurology Clinical Research Center listed below.

 

Dr. Ahern/Dr. Hishaw’s Team


Eddie Soto, CCRP
Research Specialist, Senior
(520) 626-3576
esoto@neurology.arizona.edu

 

 

 

Derek Gin
Study Coordinator
(520) 626-9064
dgin2@neurology.arizona.edu

 

University of Arizona, Health Sciences, Department of Neurology
1501 N. Campbell Avenue
Tucson, AZ 85724
Fax: (520) 626-4903

 

Dr. Rapcsak's Team:
Kim Corley
Research Specialist
(520) 331-1938
kgcorley@email.arizona.edu

University of Arizona, Health Sciences, Department of Neurology
1501 N. Campbell Avenue
Tucson, AZ 85724
Fax: (520) 626-2111

 

Participants will receive, at no charge, the investigational drug and any procedures, testing and evaluations required by the protocol.