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)
- 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
- 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
- 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.
o 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.
o 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.
o 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.
- 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.
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
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
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 firstname.lastname@example.org
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:
University of Arizona, Health Science Center, Department of Neurology
1501 N. Campbell Avenue, Room 6230
Tucson, AZ 85724-5023
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.