Active Trials (Not Recruiting)
Observational Studies
Study Title: Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Study
Purpose
The purpose of the LEARN study is to help researchers understand the changes in thinking and memory that may occur in older individuals. The LEARN study is a longitudinal study designed to compare the natural course of aging in individuals with normal cognition who do not have elevated amyloid levels in the brain, to individuals with normal cognition and elevated amyloid brain levels who are enrolled in the A4 Trial (information below). This will be achieved through collection of cognitive, clinical, and biomarker measures (imaging, blood, CSF). Other goals of this study include 1) exploring which cognitive and clinical characteristics predict changes in non-elevated amyloid individuals, 2) evaluating longitudinal changes in amyloid accumulation and neurodegeneration in non-elevated amyloid individuals, and 3) exploring the psychological impact of disclosure of amyloid status to participants, by using questionnaires which probe perception of amyloid imaging and concern about developing Alzheimer's disease. This study will consist of 11 visits over 4.5 years. (PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Development Program)
Contact: Thao Rodriguez at (310) 794-6191 or send an email to TTRodriguez@mednet.ucla.edu for more information.
Sponsor: University of Southern California
ClinicalTrials.gov Identifier: NCT02488720
Condition: Cognitive Disorders
Study Type: Observational
Official Title: Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study. A Companion Observational Study to Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Trial
Source: ClinicalTrials.gov
Ages Eligible for Study: 65 Years to 85 Years (Older Adult)
Genders Eligible for Study: All
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample
Inclusion Criteria:
- Consented to participate in the A4 study and previously met A4 demographic, cognitive and clinical criteria (e.g., Mini-Mental State Examination (MMSE); Clinical Dementia Ratin (CDR); Logical Memory test, part IIa (LMIIa); medications; medical history).
- Has a florbetapir PET scan that falls below the Aβ threshold levels required for randomization into the treatment arms of the A4 trial.
- In general, permitted medications should be stable for 8 weeks prior to LEARN Visit 1.Changes to medications that, in the opinion of the investigator, are not likely to impact LEARN Visit 1 assessments are permissible.
- Has a study partner that is willing to participate as a source of information and has at least weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject's daily function.
- In the investigator's opinion, is both willing and able to participate in all required procedures for the duration of the study (at least 240 weeks), including adequate literacy in English or Spanish and adequate vision and hearing to complete the required psychometric tests.
Exclusion Criteria:
- Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at LEARN Visit 1.
- Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study.
- Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
- Has a LEARN Visit 1 MRI scan with results showing >4 hemosiderin deposits (definite microhemorrhages or areas of superficial siderosis); or any amyloid-related imaging abnormalities - edema/effusions (ARIA-E).
- Has received any exclusionary medication, including those with significant central nervous system (CNS) anticholinergic effects, within 3 months prior to LEARN Visit 1 or initiated at any point after screen. A full list of exclusionary medication will be provided in the relevant procedures manual.
- Is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participation in observational studies may be permitted upon review of the observational study protocol and approval by the Project Director or one of the ADCS Medical Monitors.
- For subjects participating in the optional Lumbar Puncture (LP, all of the above, plus:
Current use of anticoagulants, such as warfarin or dabigatran.)
Interventional Studies
Study Title: A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease (Autonomy)
Purpose
The Autonomy Study will see if the investigational medicine may stop abnormal tau from spreading in the brain, and slow memory loss. Tau is a protein found in the brain. In people with AD, an abnormal form of tau builds up in the brain and may cause memory loss. If a potential participant meets all study eligibility criteria, the presence of abnormal tau in their brain will be evaluated. The Autonomy Study will include about 420 participants. Each participant could be in the study for up to 5 years; however, most participants will be in the study for 3 years or less. The study will involve up to 65 visits to the study center. In this study, the investigational medicine is being compared with a placebo. A placebo looks just like the investigational medicine and is given in the same way, but it does not contain any active ingredients. Participants will receive either the investigational medicine or the placebo every 4 weeks.
Anyone interested may be able to take part if they:
- are 55–80 years of age
- are experiencing a gradual decline in their cognitive abilities (e.g. memory, problem-solving skills, and ability to pay attention and think clearly) over at least the past 6 months or have been diagnosed with early AD
- have a reliable close friend, relative, or spouse who can be their study partner. This should be someone who spends at least 10 hours every week with them, knows their daily functioning well, and is able to accompany them to visits to the study center.
(PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Development Program)
Contact: Thao Rodriguez at (310) 794-6191 or send an email to TTRodriguez@mednet.ucla.edu for more information.
Sponsor: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04619420
Condition: Alzheimer's Disease, Cognitive Dysfunction, and Dementia
Study Type: Interventional (Clinical Trial)
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease
Source: ClinicalTrials.gov
Study Title: Confirm Safety and Efficacy of BAN2401 Anti-Amyloid-beta Immunotherapy in Participants With Early Alzheimer's Disease (Clarity AD)
Purpose
The Kagan Clinical Trial Program is conducting an Eisai funded study called BAN2401 anti-amyloid-beta. The primary objective is to evaluate the efficacy of BAN2401 anti-amyloid-beta, investigational agent in subjects with early Alzheimer’s disease (EAD) compared to Placebo. The key measure used to determine if BAN2401 anti-amyloid-beta compared with placebo is the Clinical Dementia Rating–Sum of Boxes (CDR-SB) which will be used to compare change of scores from baseline to the 18-month time point. Participants will undergo an hour-long infusion every 2 weeks along with neuropsychological assessments, MRI and PETs at various time points throughout the study. The study is free and voluntary. It is approximately 18 months long, with up to 5 visits within the first 90 days of screen. This study does have an extension phase for up to 2 years after the initial 18 months have been completed or until commercial availability of BAN2401 anti-amyloid-beta or until a positive risk benefit assessment in this indication is not demonstrated. Enrollment is open to patients with a diagnosis of Mild Alzheimer’s disease or Mild Cognitive Impairment due to AD who are between the ages of 50 and 90 years old. (PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Development Program)
Contact: Thao Rodriguez at (310) 794-6191 or send an email to TTRodriguez@mednet.ucla.edu for more information.
Sponsor: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03887455
Condition: Early Alzheimer's Disease
Study Type: Interventional (Clinical Trial)
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
Source: ClinicalTrials.gov
Ages Eligible for Study: 50 Years to 90 Years (Adult, Older Adult)
Genders Eligible for Study: All
Study Title: Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in Aducanumab Studies (EMBARK)
Purpose
The Biogen EMBARK study is a Phase 3 study evaluating the long-term safety and tolerability of aducanumab (Aduhelm) after a wash-out period imposed by discontinuation of earlier studies. This study enrolled participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants). This study is not recruiting new participants at this time. During the study, participants will receive the study drug, aducanumab (Aduhelm) at a dose of 10mg/kg by intravenous infusions every four weeks for a total duration of 100 weeks. Study visits consist of regular safety tests and cognitive assessments throughout the study. At the end of the study, there is a follow-up period which involves returning to the study center approximately 2 weeks after a participant’s last dose of aducanumab for clinical assessments. Participants will also return to the study center for a safety follow-up visit about 18 weeks (about 4 months) after their last dose of the study drug. (PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Dev. Program)
Contact: Thao Rodriguez at (310) 794-6191 or send an email to TTRodriguez@mednet.ucla.edu for more information.
Sponsor: Biogen
ClinicalTrials.gov Identifier: NCT04241068
Condition: Alzheimer's Disease
Intervention:
Drug: Aducanumab
Other Name: BIIB037
Phase: Phase III
Study Type: Interventional
Estimated Enrollment: 1695 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
Length of Study: Up to Week 118
Source: ClinicalTrials.gov
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Inclusion Criteria:
- The participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies).
- Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.
Exclusion Criteria:
- Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment.
- Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
- Clinically significant unstable psychiatric illness in past 6 months.
- History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening.
- A seizure event that occurred after the last visit of the feeder study and before Screening for this study.
- Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.
- History of or known seropositivity for HIV.
- Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.
- Contraindications to having a brain magnetic resonance imaging (MRI).
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Title: A Research Study Investigating Semaglutide in People with Early Alzheimer's Disease (EVOKE and EVOKE Plus)
Purpose
The primary goal of the EVOKE and EVOKE+ study is to confirm the superiority of oral Semaglutide versus placebo on the change in cognition and function in patients with mild cognitive impairment (MCI) and mild Alzheimer’s disease. Semaglutide is a medication currently used to treat type 2 diabetes. Semaglutide may also reduce systemic inflammation. Approximately 2000 people will participate in this trial at sites around the world. The study duration is 3 years and 4 months with a screening period (up to 12 weeks), main double-blind phase (104 weeks), an open-label extension phase (52 weeks), and a follow-up visit (5 weeks). In total, there will be 18 visits. (Principal Investigator: Leila Parand, MD, Easton Center’s Katherine and Benjamin Kagan Alzheimer’s Disease Treatment Development Program)
Contact: Thao Rodriguez at (310) 794-6191 or send an email to TTRodriguez@mednet.ucla.edu for more information.
Sponsor: Novo Nordisk A/S
ClinicalTrials.gov Identifier: EVOKE study (NCT04777396) and EVOKE+ study (NCT04777409)
Condition: Early Alzheimer's Disease
Intervention:
Drug: Semaglutide
Drug: Placebo (semaglutide)
Phase: Phase III
Study Type: Interventional
Study Design:
Allocation: A Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE) and A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)
Length of Study: The study will last for up to 173 weeks.
Source: ClinicalTrials.gov
Study Title: The Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Study
Purpose
The A4 Study is a clinical study for older individuals (ages 65-85) who have normal thinking and memory function but who may be at risk for developing Alzheimer's disease (AD) memory loss sometime in the future. The A4 study is for people without any outward signs of Alzheimer's disease, and is designed to evaluate the effectiveness, safety and tolerability of an investigational drug for AD. The purpose of the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the "A4 study" for short) is to test whether a new investigational treatment can slow the memory loss caused by Alzheimer's disease. The overall goal of the A4 study is to test whether decreasing amyloid with antibody investigational treatment can help slow the memory loss associated with amyloid buildup in some people. The A4 Study lasts for three years, and participants will be assigned at random to receive either the investigational drug or a placebo and will be monitored over that period. (PI: Maryam Beigi, MD, Easton Center’s Katherine and Benjamin Kagan Alzheimer’s Disease Treatment Development Program)
Contact: Thao Rodriguez at (310) 794-6191 or send an email to TTRodriguez@mednet.ucla.edu for more information.
Sponsor: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02008357
Condition: Cognition Disorders
Intervention:
Drug: Solanezumab
Drug: Placebo
Phase: Phase III
Study Type: Interventional
Study Design:
Allocation: A Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blinded (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
Length of Study: 168 Weeks; Study treatments will take place once every 4 weeks.
Source: ClinicalTrials.gov
Ages Eligible for Study: 65 Years to 85 Years
Genders Eligible for Study: Both
Inclusion Criteria:
- Has a Mini-Mental State Examination (MMSE) score at screening of 27 through 30 for participants with high educational attainment (13 or more years of education) or 25 to 30 for participants with low educational attainment (12 or fewer years of education).
- Has a global Clinical Dementia Rating (CDR) scale score at screening of 0.
- Has a Logical Memory II score at screening of 15 to 8 for participants with high educational attainment (13 or more years of education) or 13 to 6 for participants with low educational attainment (12 or fewer years of education).
- Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain amyloid pathology at screening.
- Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication).
Exclusion Criteria:
- Is receiving acetylcholinesterase inhibitor (AChEI) and/or memantine at screening or baseline.
- Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded.
- Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study.
- Has had a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness.
- Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen posttreatment.
- Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis).
- Is clinically judged by the investigator to be at serious risk for suicide.
- Has a history within the past 2 years of major depression or bipolar disorder as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM.
- Have changes in medications or doses of medication in past 4 weeks.