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. 

 

BAN2401-G000-201 is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of subjects and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of subjects.

Subjects will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint.

You may be eligible to participate if you:

·         Are between 50 and 90 years of age

·         Have history of subjective memory decline with gradual onset and slow progression

This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT01767311


Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) versus Placebo (H8A-MC-LZAX) 
[Study Sponsor: Eli Lilly and Company; Principal Investigator: Geoffrey Ahern, MD, PhD]  
 
The primary objective of this study is to test the hypothesis that solanezumab, administered as an intravenous infusion at a dose of 400 mg every 4 weeks for 76 weeks, will slow the cognitive and functional decline of Alzheimer's disease (AD) as compared with placebo in patients with mild AD. 
 
The duration of this trial is 20 months. Participants will receive, at no charge, the investigational drug, physical and neurological exams, laboratory services, magnetic resonance imaging (MRI), positron emission tomography (PET) scanning and medical monitoring by a nurse and physician. Participants will be compensated for their time and travel. 
 
You may be eligible to participate if you:
  • Are between 55 and 90 years of age
  • Have a diagnosis of mild AD
  • Are on a stable dose of medications to treat memory loss or not currently being treated
  • Have a caregiver who is willing to be involved in the study with you
Study participants will be asked to:
  • Attend a total of 23 study visits
  • Receive 30-minute infusions of investigational drug, once a month for 76 weeks
  • Undertake cognitive assessments for clinical evaluation and efficacy 
  • Receive pharmacogenomic (APOE4 ) and other blood sampling
  • Undergo PET and MRI imaging procedures for clinical and safety assessments

Alzheimer's Disease Core Center & Arizona Alzheimer's Disease Consortium
(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. 


 
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week, Phase 3 Study of Two Doses of EVP-6124 or Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
 
[Study Sponsor: FORUM Pharmaceuticals, Inc.; Principal Investigator: Geoffrey Ahern, MD, PhD]
 
This study is being done to see if EVP-6124, an investigational “study drug,” is safe and effective for people with mild to moderate dementia due to Alzheimer’s disease (AD).  EVP-6124 is a drug that targets certain areas in the brain containing neuronal nicotinic acetylcholine receptors (nAChRs).  These receptors are important for cognitive and memory functions.
 
You may be eligible to participate if you:
•Are between 55 and 85 years of age
•Have a diagnosis of dementia due to probable AD
•Are currently receiving a stable dose of medications to treat memory loss
•Have previously been treated with acetylcholinesterase inhibitors (AChEI) such as: donepezil, rivastigmine, or galantamine
•Have a reliable caregiver who is willing to be involved in the study with you
 
Study participants will be asked to:
•Attend at least 10 study visits (total duration of study is approximately 34 weeks)
•Receive either EVP-6124 or placebo for 26 weeks
•Undertake cognitive assessments for clinical evaluation and efficacy
•Receive 8 blood draws over the course of the study for clinical assessments
•Undergo MRI or CT imaging procedures for safety assessments
 
Participants will not be charged for any study visits, procedures, tests, or study drug they receive.  Participants will be compensated for their time and travel.
 

 

A Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of T-817MA in patients with mild to moderate Alzheimer’s Disease

 [Study Sponsor: Toyama Chemical Co., Ltd.; Principal Investigator: Alex G. Hishaw, MD]

 You may be eligible to participate if you:

•Are between 55 and 85 years of age

•Have a diagnosis of mild to moderate Alzheimer’s Disease

•Are currently receiving donepezil (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system.

•Have an eligible informant and study partner  

 This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT02079909


Participants will not be charged for any study visits, procedures, tests, or study drug they receive.  Participants will be compensated for their time and travel.

If you are interested in seeing if someone you know is eligible to participate in any of these studies or if you would like more information, please contact:

Dr. Ahern/Dr. Hishaw’s Team                                                                                                                                                        Emily K. Dolezal , CCRP                                                                                                                                                                   Senior Research Specialist                                                                                                                                                               (520) 626-3576                                                                                                                                                                             dolezale@neurology.arizona.edu

 

University of Arizona, Health Science Center, Department of Neurology                                                                                           1501 N. Campbell Avenue, Room 7329                                                                                                                                           Tucson, AZ 85724-5023                                                                                                                                                                 Fax: 520-626-4903

 

Dr. Rapcsak's Team:

Kim Corley
Research Specialist
(520) 331-1938
kgcorley@email.arizona.edu

University of Arizona, Health Science Center, Department of Neurology
1501 N. Campbell Avenue, Room 6230
Tucson, AZ 85724-5023
Fax: 520-626-2111 

Participants will receive, at no charge, the investigational drug and any procedures, testing and evaluations required by the protocol.  Participants will also be compensated for their time and travel.