Research Studies
Research Activities at the Layton Aging and Alzheimer's Disease Center are organized into various categories:
Clinical Trials and Intervention Studies currently recruiting Participants
Alzheimer's Disease Studies
Lipoic Acid and omega-3 fatty acids in Alzheimer’s disease
Alzheimer’s Disease Neuroimaging Initiative 2 (ADNI-2)
Title: Alzheimer’s Disease Neuroimaging Initiative 2 (ADNI-2)
Principal Investigator: Dr. Jeffrey Kaye
Sponsor: NIH, NIA (ADCS study)
Length: 5 years Visits: 8 clinic visits , 5 phone calls, 2 Lumbar Punctures, 4 PET scans, and MRIs at baseline, month 3, month 6 and ongoing annually
Purpose: To determine the relationships among clinical, imaging, genetic, and biochemical marker characteristics of the entire spectrum of Alzheimer’s Disease, as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment, to dementia.
Also to identify diagnostic and prognostic markers, identify outcome measure for clinical trials, develop improved methods which will lead to uniform standards, enroll 550 newly enrolled subjects, continue to follow already enrolled subjects from ADNI 1 and ADNI GO, and validate clinical diagnoses and imaging and biomarker surrogates through neuropathological examination.
Study design: This is a non-randomized natural history non-treatment study.
Procedures: Visits-Screening, Baseline, then yearly phone calls- every 6 months in between yearly visits MRIs – screening, month 3, month 6, then ongoing yearly. PET scans – 2 at baseline, 2 at year 2, 2 at year 4. LP – one at baseline, optional at year 2.
All subjects will have clinical/cognitive assessments, biomarker collections, and imaging, including F18 amyloid imaging (PET scan), FDG PET, 3T MRI, and LP.
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 65-90
• MMSE 20-30
• Has a study partner willing to accompany the subject to all clinic visits
• Must be willing to undergo all test procedures, including an LP at baseline
Contact: Raina Carter at 503-494-9399, carterra@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
Title: 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
Title: 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: Alison Rhoads 503-494-9399, rhoadsa@ohsu.edu
Caregiver Studies
Meditation or education for Alzheimer caregivers: stress and physiology (aka The Alzheimer's Caregiver study)
Long Term Longitudinal Community Studies
These studies provide a clinical assessment of a patient over a long period of time in order to investigate disease course and risk factors.
OBAS - Oregon Brain Aging Study focuses on identifying factors that protect individuals from developing dementia in later life and promote a maximal cognitive health span.
CBDP - Community Brain Donor Program
AADAPt - The African American Dementia and Aging Project is a longitudinal study of brain aging in elderly African Americans in Northeast Portland.
KEAP - Klamath Exceptional Aging project is a community based study that follows longitudinally, rural residing persons 85 or older in the Klamath basin of Oregon.
ISAAC – Intelligent Systems for Assessment of Aging Changes Study
