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    Alzheimer's Disease Clinical Trials

    Sutter Health participates in clinical trials related to Alzheimer's Disease throughout their Northern California facilities. See the listing below for an overview of current trials, including contact information. For some trials, more detailed information can be found via the title link to ClinicalTrials.gov.

    Title: IDEAS - Imaging Dementia - Evidence for Amyloid Scanning Description: This study will assess the impact of obtaining results to amyloid PET scans on patient outcomes under Coverage with Evidence (CED) in patients with mild cognitive impairment or dementia of unknown etiology. It is hypothesized is that results to amyloid PET scans will increase confidence in the underlying cause of cognitive impairment which will translate into interventions that lead to improved patient outcomes.
    Investigator: Annie Lai, MD
    Eligibility: Participants will be eligible if they are over the age of 65 and there is diagnostic uncertainty about the cause of their cognitive impairment (mild cognitive impairment or dementia) even after a comprehensive clinical evaluation by a dementia expert including laboratory tests (complete blood count, comprehensive metabolic panel, thyroid function tests and vitamin B12 level) and structural brain imaging (CT or MRI).
    Status: Active and open to enrollment
    Location: Alta Bates Summit Medical Center
    Contact: Alyssa Ferdinando, 510-204-1610
    Email: FerdinA1@sutterhealth.org

    Title: The Synchronous Sign Study
    Description: This study is to determine whether a movement assessment called the synchronous sign can point out the difference in patients with Lewy body symptoms from those with other conditions such as Alzheimer disease.
    Investigator: Shawn Kile, MD
    Eligibility: Participants are referred from the PI or sub-I's with a either MCI or AD and a positive amyloid PET scan, or PD or DLB with a positive DAT scan.
    Status: Active and enrolling
    Location: Sutter Medical Center, Sacramento | Sutter Institute for Medical Research
    Contact: Tammy Donnel
    Email: donnelt@sutterhealth.org

    Title: Anti-amyloid treatment in asymptomatic Alzheimer's Disease (A4 Study)
    Description: This study is to test solanezumab administered as an intravenous infusion every 4 weeks for 3 years in patients with preclinical AD. The primary objective is to test the hypothesis that solanezumab with slow cognitive decline as compared with the placebo subjects with preclinical AD.
    Investigator: Shawn Kile, MD
    Eligibility: Participants ages 65 to 85 who may be at risk for memory loss. Must have a screening MMSE score of 25 to 30 and must have a evidence of brain amyloid pathology based on screening florbetapir PET scan. Participants must have a trial partner that has at least weekly contact with the participant and willing to attend study visits.
    Status: Pending IRB approval; not currently enrolling
    Location: Sutter Medical Center, Sacramento | Sutter Institute for Medical Research
    Contact: Tammy Donnel
    Email: donnelt@sutterhealth.org

    Title: A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (HEADWAY-DLB) Protocol RVT-101-2001
    Description: This study is to determine the safety and efficacy of RVT-101 at doses of 70mg and 35 mg daily over a 24 week treatment period in patients with DLB with or without existing background therapy.
    Investigator: Shawn Kile, MD
    Eligibility: Participants ages 50 to 85 with a diagnosis of probable dementia with Lewy Bodies with an MMSE of 14-26, inclusive, at screening. Participant must have a regular caregiver who is willing to attend study visits, oversee the administration of the study medication, and either live with the participant or have a minimum of 10 hours over at least 3 days contact with the participant per week.
    Status: Pending IRB approval; not currently enrolling
    Location: Sutter Medical Center, Sacramento | Sutter Institute for Medical Research
    Contact: Tammy Donnel
    Email: donnelt@sutterhealth.org

    Title: Effect of LY32002626 on Alzheimer's Disease Progression as measured by Cerebral 18F-AV-1451 Tau_PET in Mild Alzheimer's Disease Dementia (NAVIGATE-AD) Protocol 17X-MC-LLCF
    Description: This study is to assess the change from baseline in 18F-AV-1541 PET after treatment with LY3202626 3 mg and 12 mg per day compared with placebo for 52 weeks among patients with mild AD and evidence of brain amyloid.
    Investigator: Shawn Kile, MD
    Eligibility: Participants ages 55 to 85 with a mild AD dementia and a screening MMSE of 20-26 score. Participant must have a trail partner/caregiver who is willing to attend study visits, oversee the administration of study medication, and have face-to-face contact with the participant for a minimum of 10 waking hours per week. Participante cannot have a severe allergy to 2 or more drug classes.
    Status: Active and open to enrollment soon - Oct 2016
    Location: Sutter Medical Center, Sacramento | Sutter Institute for Medical Research
    Contact: Tammy Donnel
    Email: donnelt@sutterhealth.org

    Title: IDEAS - Imaging Dementia - Evidence for Amyloid Scanning
    Description: This study will assess the impact of obtaining results to amyloid PET scans on patient outcomes under Coverage with Evidence (CED) in patients with mild cognitive impairment or dementia of unknown etiology. It is hypothesized is that results to amyloid PET scans will increase confidence in the underlying cause of cognitive impairment which will translate into interventions that lead to improved patient outcomes.
    Investigator: Shawn Kile, MD
    Eligibility: Participants will be eligible if they are over the age of 65 and there is diagnostic uncertainty about the cause of their cognitive impairment (mild cognitive impairment or dementia) even after a comprehensive clinical evaluation by a dementia expert including laboratory tests (complete blood count, comprehensive metabolic panel, thyroid function tests and vitamin B12 level) and structural brain imaging (CT or MRI).
    Status: Active and open to enrollment
    Location: Sutter Medical Center, Sacramento | Sutter Institute for Medical Research
    Contact: Janet Vulk, 916-453-5845
    Email: VulkJ@sutterhealth.org

    Title: 18F-AV-1451 Tau PET Imaging Study
    Description: This study will assess the relationship between ante-mortem 18F-AV-1451 Positron Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with Alzheimer's disease, as measured at autopsy.
    Investigators: Alireza Atri, MD, PhD
    Eligibility: Participants will be eligible if they are 50 years or older, who have a projected life expectancy of ≤ 6 months, can tolerate a 20 minute PET scan, and are willing to donate their brain at death for autopsy to compare with PET scan findings. We are seeking participants with normal cognition as well as Mild Cognitive Impairment or Dementia.
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Amber Lee, 415-600-5568
    Email: LeeAJ@sutterhealth.org

    Title: A Randomized Double-Blinded Placebo-Controlled Exploratory Study of Intravenous Immunoglobulin (NewGam 10%) in Amnestic Mild Cognitive Impairment (Protocol IVIG-Kile-032010)Opens in a new windowexternal site
    Description: This study will evaluate the efficacy of intravenous immunoglobulin in patients with Mild Cognitive Impairment for prevention or delaying progression to Alzheimer Disease Dementia over 24 months after the infusions . This study will also document brain volumetrics.
    Investigator: Shawn Kile, MD
    Eligibility: Age from 50 to > 85 years old. Diagnosis of Mild Cognitive Impairment, Amnestic type.
    Status: Active and open to enrollment
    Location: Sutter Medical Center, Sacramento
    Contact: Tammy Donnel, CRC 916-453-5994 Email: Donnelt@sutterhealth.org

    Title: A Randomized, Placebo Controlled, Parallel-Group, Double Blind Efficacy and Safety Trial of MK-8931 in Subjects with Mild to Moderate Alzheimer's Disease
    Description: The purpose of this study is to assess the efficacy and safety of MK-8931 compared with placebo in the treatment of Alzheimer's Disease (AD). The primary study hypotheses are that at least one MK-8931 dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and that at least one MK-8931 dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score.
    Investigator: Shawn Kile, MD
    Eligibility: Patients 55-85 with mild to moderate Alzheimer's disease with a reliable trial partner that has a close relationship to the patient. Patient must be comfortable undergoing MRI and eye exams. Patient cannot have allergies or hypersensitivity reactions to more than 3 medications.
    Status: Active and open to enrollment.
    Location: Sutter Medical Group | Sutter Institute for Medical Research
    Contact: Tammy Donnel, CRC, 916-453-5994
    Email: Donnelt@sutterhealth.org
    Sponsor: Merck Sharp & Dohme Corp

    Title: A Phase III, Randomized, Placebo-Controlled, Paralle-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal AD).
    Description: The purpose of this study is to assess the efficacy and safety of MK-8931 compared with placebo in the treatment of Amnestic Mild Cognitive Impairment (aMCI). The primary study hypothesis is that at least one MK-8931 dose is superior to placebo with respect to he change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at 104 weeks.
    Investigator: Shawn Kile, MD
    Eligibility: Patients 50-85 with amenstic mild cognitive impairment and a reliable trial partner that has a close relationship to the patient. Patient must be comfortable undergoing MRI, eye exams and PET scan. Patient cannot have allergies or hypersensitivity reactions to more than 3 medications.
    Status: Active and closed to enrollment
    Location: Sutter Medical Group
    Contact: Tammy Donnel, CRC, 916-453-5994
    Email: Donnelt@sutterhealth.org
    Sponsor: Merck Sharp & Dohme Corp

    Title: An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects with Mild Cognitive Impairment, and Subjects with Alzheimer's Disease.
    Description: This is a Phase II cross-sectional and lognitudinal observational study that will evaluate imaging characteristics of 18F-AV-1451 in cognitive healthy control subjects and patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD).
    Investigator: Stephen Falen, MD
    Eligibility: All patients must be able to tolerate MRI and PET scan imaging procedures and undergo cognitive assessments. Cognitive healthy subjects must be either ages 20-40 or over 50 yrs of age. MCI and AD patients must be over 50 yrs of age and have a trial partner that has a close relationship to the patient.
    Status: Active and open to enrollment
    Location: Sutter Medical Group
    Contact: Tammy Donnel, CRC, 916-453-5994
    Email: Donnelt@sutterhealth.org
    Sponsor: Merck Sharp & Dohme Corp


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