Clinical Trials
The Kulynych Center for Memory and Cognition Research is involved in and sponsors many studies relating to dementia, Alzheimer's, cognition and memory loss.
Clinical trials that are currently underway:
AV-45-A11
Observational study of long-term (18 month) cognitive outcomes in healthy volunteers, patients with mild cognitive impairment (MCI) and patients with Alzheimer’s disease (AD) who have previously had PET imaging with 18F-AV-45
Sponsored by Avid Radiopharmaceuticals, Inc.
18F-AV-45 is a new molecular imaging agent that may allow doctors to image changes in the brain of patients with Alzheimer’s disease using a PET (Positron Emission Tomography) scan machine. People who have previously participated in the AV-45-A05 study in which they had PET imaging with 18F-AV-45 were asked to participate in the AV-45-A11 study. The purpose of this study is to obtain information about the clinical and cognitive status of subjects 18 months after they were imaged in the previous study.
It is known that a protein peptide called amyloid-ß peptide or simply Aß accumulates in the brains of patients with Alzheimer’s disease. These accumulations are called amyloid plaques. 18F-AV-45 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera. Therefore, it may be possible to detect amyloid plaques in patients with Alzheimer’s disease by the amount of 18F-AV-45 radioactive signal seen on a PET scan. The amount 18F-AV-45 signal in the brain detected by the PET scanner may be useful to detect Alzheimer’s disease (AD) and to predict change in cognition over time.
A total of 180 people at 24 research sites are currently taking part in this study. They will continue their participation for about 18 months.
BMS CN156-018
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmocodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients with Prodromal Alzheimer's Disease.
Sponsored by Bristol-Myers Squibb Company
The purpose of this research study is to test the safety and tolerability of an investigational drug, BMS-708163, compared to placebo (inactive substance) in subjects with prodromal Alzheimer’s disease. Prodromal Alzheimer’s disease refers to the early stage or beginnings of the disease. In this study participants will receive the active study medication, BMS-708163 or placebo. Placebos are used in research studies to see if the drug being studied really does have an effect. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA).
There are 60 - 70 study sites taking part throughout the U.S., Canada, France, Sweden, Finland, Denmark, and Netherlands. A total of 270 male and female participants, 45 - 90 years of age with complaints of memory loss are being recruited. The treatment period for the study will be a minimum of approximately 104 weeks (2 years). All randomized patients will continue in the study until the last randomized patient has had the opportunity to receive study medication for 104 weeks. As the primary objective of this study is the assessment of safety and tolerability, the primary endpoints will include vital signs, laboratory tests, physical / neurological examination findings, AEs, SAEs, reasons for discontinuation, and rates of early discontinuation from the study.
Alzheimer’s disease is the most common form of dementia. It is a progressive and fatal brain disease. Alzheimer's destroys brain cells, causing memory loss and problems with thinking and behavior severe enough to affect work, lifelong hobbies or social life. Alzheimer’s gets worse over time, and it is fatal. Today as many as 5.3 million Americans are living with Alzheimer’s disease.
To learn more about the BMS CN156-018 study please call 1-877-238-4825 or visit
http://clinicaltrials.gov/show/NCT00890890
S-Connect
A Randomized Controlled Trial to Assess the Efficacy of a Medical Food in Patients with Mild to Moderate Alzheimer’s Disease using Alzheimer’s Disease Medication
Sponsored by Danone Research
Study Overview:
This study will evaluate the effect of a nutritional drink on memory and thinking function compared to a control drink in people with mild to moderate-stage Alzheimer’s Disease, who are using medication for their symptoms.
Background:
Approximately 500 patients with mild to moderate Alzheimer’s Disease will be randomly assigned to either the investigational or control arm for a period of 24 weeks. At baseline, 12, and 24 weeks the major study parameters are assessed. To keep patients motivated and to dispense study product, additional visits are conducted at weeks 6 and 18. For motivation and compliance, phone calls are conducted at 3, 9, 15, and 21 weeks. A final follow-up call will follow around 2 weeks after the final site visit.
HBA
Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old
Sponsored by Alzheimer’s Disease Cooperative Study, through a grant from the National Institute on Aging (NIA)
The primary objective of this study is to develop more efficient and sensitive home-based testing methods in elderly subjects at risk for memory problems and Alzheimer’s disease. This study is looking at three different at-home information collection methods and will compare them with traditional in-clinic information collection. The three methods of information collection are: Mail-in questionnaires (plus memory and thinking skills test done by telephone), Automated telephone technology and Computer-Based Kiosk.
Approximately 600 people, 200 in each assigned arm, are enrolled in this 4-year trial, which includes 30 sites in the United States. All eligible subjects have been randomly assigned to an assessment method and to a frequency of assessment. In addition, all subjects have been provided a multi-vitamin to be taken twice a day, and a measure of medication adherence will be collected for each assessment method. Based on existing data, a predefined score on a specific cognitive and functional measures will be used to identify a point of significant impairment that will “trigger” an in-person assessment. The study estimates that 12-13% of the study population will reach the trigger point over the 4 years of the study and will progress to a more impaired diagnostic category. At the end of the 4 years study period all subjects will undergo an in-person evaluation.
To learn more about the HBA study please call 1-877-238-4825 or visit
http://www.adcs.org/Studies/HBA.aspx
ICARA
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Mild to Moderate Alzheimer’s Disease Who Are Apolipoprotein E-4 Carriers & Non-Carriers
Sponsored by JANSSEN Alzheimer Immunotherapy Research & Development, LLC
The purpose of this research study is to assess whether a new drug called bapineuzumab is safe, well tolerated and effective for use in participants 50 - 88 years of age with Alzheimer’s disease. 1950 subjects will be enrolled in this study which includes approximately 200-250 sites in the United States and Canada.
Bapineuzumab is an investigational (not FDA approved) drug being studied for the treatment of Alzheimer’s disease.
In this study participants will either receive the active study drug, bapineuzumab, or placebo (non-active substance).
To learn more about the ICARA study please call 1-877-238-4825 or visit
http://clinicaltrials.gov/ct2/show/NCT00574132
IDENTITY
Effect of γ-Secretase Inhibition on the Progression of Alzheimer’s Disease: LY450139 versus Placebo
Sponsored by Eli Lilly and Company
Alzheimer's disease (AD) is an incurable, fatal degenerative disease of the brain. AD is thought to be caused by an excess of A-β amyloid, a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. In Phase I studies, inhibiting the enzyme γ-secretase inhibits the production of A-βamyloid as measured in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far.
This study will use several different tests to measure the effect of LY450139 on both A-βamyloid and amyloid plaques for some patients. The buildup of amyloid plaques will be measured by a new type of brain scan that can take a picture of amyloid plaques in the brain. Other tests will attempt to measure the overall function of the brain and brain size in some patients. The primary purpose of this study is to help answer whether LY450139 can help patients with mild to moderate Alzheimer’s disease. The safety of LY450139 and any side effects that might be associated with it will be assessed.
Participants are currently receiving the active study medication, LY450139, or placebo (a non-active substance). Placebos are used in research studies to see if the drug being studied really does have an effect.
Up to 1500 people will be participating in this study for approximately 2 years at 148 study sites throughout the world.
LY450139 is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA).
To learn more about the IDENTITY study please call 1-877-238-4825 or visit http://clinicaltrials.gov/ct2/show/NCT00594568