OHSU

Alzheimer's Disease Studies

Eisai BAN2401-G000-201

Principal Investigator: Dr. Joseph Quinn
Sponsor: Eisai Inc.
Length: 18 months, Visits:  43 clinic visits, 3 PET scans, 8 MRI, and 3 optional Lumbar Punctures

Purpose: The purpose of this study is to learn more about Alzheimer’s Disease. In this study, we will learn about a drug called BAN2401. This study is designed to determine if the study drug has a benefit on a person’s cognitive status and assess the safety and tolerability of the study drug for subjects with early Alzheimer’s Disease (Mild Cognitive Impairment due to Alzheimer’s Disease or mild Alzheimer’s Disease).

Study design: A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease.

Procedures: Visits-Screening, Baseline, then biweekly infusions.  MRIs – screening, visit 9, visit 16, visit 22, visit 29, visit 35, visit 42, and follow-up visit.  PET scans – baseline, visit 29, and visit 29. Optional LP – one at baseline, visit 29 and visit 42. All subjects will have clinical/cognitive assessments, and biomarker collections.

Study Care and Reimbursement:  Study visits provided at no charge.  Subjects will be reimbursed for each study visit.

Seeking Volunteers:

•    This study is accepting new subjects that have Alzheimer’s Disease, or mild memory complaints.  (Please contact study coordinator for further details).
•    Age 50-90
•    MMSE 22-30
•    Has a study partner willing to accompany the subject to all clinic visits
•    Must be willing to undergo all test procedures, with the option of the lumbar puncture

Contact:  Monika Stanko, RN at 503 494-7615, stanko@ohsu.edu

 

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease

Principal Investigator:  Dr. Joseph Quinn
IRB #: 8026
3181 SW Sam Jackson Park Road, CR131
Portland, Or.  97239
Sponsor: Hoffman - La Roche
Length and Visits: Approximately 2 years and 5 months which includes 8 weeks for screening, 104 weeks of treatment and 12 weeks of follow-up.

Purpose: To evaluate the effect of gantenerumab vs. placebo on cognition, functioning, neuropsychiatric functioning on people with Mild Cognitive Impairment otherwise called by the sponsor “prodromal Alzheimers disease”. The study will also evaluate safety and tolerability of study drug, the brain on MRI scans, and will assess genetic and pharmacokinetic factors.

Procedures: After written informed consent is obtained, screening assessments must be completed within 8 weeks. Entrance to the study will be based on medical history, cognitive testing, brain imaging and spinal fluid assessment.

In this study, all subjects will come in 26 times for injections.  These injections may contain the study drug or an inactive substance called a placebo.  Subjects will have a 3 in 4 chance of receiving the study drug.  There will be a 4 week interval between each dose. At some visits a brain MRI will be required with results assessed prior to dosing.  On each dosing day, gantenerumab or matching placebo will be administered as 2 subcutaneous injections in the abdominal area. Safety and efficacy evaluations will be performed according to the schedule of assessments.

All subjects will have clinical/cognitive assessments, biomarker collections, including lumbar punctures, and MRI scans

Follow-up: Patients will be followed for 12 weeks after the last dose of study treatment.

Study Care and Reimbursement:  Study visits provided at no charge.  Subjects will be reimbursed for each study visit.

Seeking Volunteers:
•    Age 50-85
•    Has Mild Cognitive Impairment
•    Has a study partner willing to accompany the subject to clinic visits
•    Must be willing to undergo all test procedures, including monthly injections of study medication, lumbar punctures, MRI scans.

Contact:  Lisa Loree 503 494-7615, loree@ohsu.edu

 

Cerebrospinal Fluid Biomarker Discovery

Principal Investigator:  Dr. Joseph Quinn                      
IRB #:  8122
Sponsor:  Phylogeny, Inc
Length and Visits:  4 visits within 1 year, first two visits required, last two visits optional but encouraged

Purpose:  The purpose of this study is to compare biomarker profiles of subjects who are healthy, have Alzheimer’s Disease, or have Parkinson’s Disease, and to examine the longitudinal stability of cerebrospinal fluid.

Study design: This is a non-randomized non-treatment study.

Length of Study: The study will last one year. The subject must complete a screening visit, baseline visit, and optional 6-month and 1-year visits.

Procedures:  The screening visit will consist of a blood draw and brief questionnaires. The qualified subject will then complete a baseline visit within one month of the screening visit, which consists of brief cognitive testing and a lumbar puncture. The subject then has the option of returning at 6 months and 12 months for repeated cognitive testing and lumbar puncture procedures.

Study Care and Reimbursement:  Study visits provided at no charge.  Subjects will be reimbursed $100 for each lumbar puncture completed.

Seeking Volunteers:
•    Age 55-80
•    Must be either Cognitively Normal, have a diagnosis of Alzheimer’s Disease, or have a diagnosis of Parkinson’s Disease
•    Has a study partner willing to accompany the subject to clinic visits
•    Must not be taking blood thinning medication such as Coumadin or Warfarin (aspirin is okay)
•    Must be willing to undergo all test procedures, including lumbar puncture and answering questionnaires and cognitive testing

Contact: Genevieve Leineweber at 503 494-0276 or leineweg@ohsu.edu