Northwestern University Feinberg School of Medicine

Mesulam Institute for Cognitive Neurology
& Alzheimer's Disease

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Asymmetric Neurodegeneration and Language in Primary Progressive Aphasia The observational primary progressive aphasia (PPA) research program at Northwestern University seeks to study individuals living with PPA over time using neuropsychological testing and advanced imaging techniques. Participants are asked to come to Chicago in order to help:better understand progression in PPA and its link to brain changes,increase … The observational primary progressive aphasia (PPA) research program at Northwestern University seeks to study individuals living with PPA over time using neuropsychological testing and advanced imaging techniques. Participants are asked to come to Chicago in order to help: better understand progression in PPA and its link to brain changes, increase awareness of PPA and better educate patients, families, and clinicians, and identify biomarkers that will lead to earlier diagnosis and earlier intervention. Participants are compensated for participation and travel expenses and meals are covered for those not local to Chicago. Eligibility CriteriaYou must carry a diagnosis of Primary Progressive Aphasia, established at a thorough evaluation prior to enrollment. If you think you may have dementia, but have not yet been evaluated, you must first undergo a clinical evaluation. This clinical evaluation is not part of the research. Patients must also meet screening criteria which require the patient to be a right-handed, native English speaker and safe to undergo a 3T MRI. Principal Investigator Mesulam, Marek-Marsel ClinicalTrials.gov IdentifierNCT00537004IRB number STU00026372 More Info Email Los, Michelle Anne Phone 312 908 9681 Copy Study URL to Clipboard Copy
Alzheimer's Disease Research Center The purpose of the Northwestern University Alzheimer’s Disease Research Center (NUADRC) study is to support clinical and basic research on memory and aging by collecting, storing, and disseminating clinical data. These data and samples include memory and thinking tests, brain imaging scans, blood samples, and brain donations. We collect … The purpose of the Northwestern University Alzheimer’s Disease Research Center (NUADRC) study is to support clinical and basic research on memory and aging by collecting, storing, and disseminating clinical data. These data and samples include memory and thinking tests, brain imaging scans, blood samples, and brain donations. We collect these data and samples from study participants who are experiencing healthy aging and those who suffer from dementia or Mild Cognitive Impairment. This study is a longitudinal, observational trial meaning that research participants will be observed over time, and data will be collected, but there is no attempt to alter the symptoms or course of disease (an intervention). Participants attend annual visits that typically last one to three hours. If participants can no longer attend in-person visits, we will continue to follow them through telephone visits with a designated study partner. This study is a multi-site study meaning Northwestern University is one of 33 sites in the United States. Research data is shared with a national database. There are currently over 15,000 participants in this study nationally with approximately 500 of them enrolled at Northwestern University. Once they enroll, most participants are referred to other research studies being led by investigators within the Mesulam Center or the greater Northwestern University scientific community. Eligibility Criteria The Northwestern University Alzheimer’s Disease Research Center (NUADRC) Clinical Core study enrolls individuals with diagnoses of Mild Cognitive Impairment, Alzheimer's disease or other dementia (frontotemporal dementia, primary progressive aphasia, Lewy Body disease and others) as well as healthy individuals with no cognitive impairment. See below for specific eligibility criteria. Patients Diagnosed with Dementia or Mild Cognitive Impairment (MCI) 18 years or older Must have had a clinical evaluation with the ability to provide medical records and doctor’s notes Speaks fluent English Ability to provide reliable study partner (someone who knows you well to provide up to date information about how you are functioning) Healthy Volunteers Over the age of 55, but some exceptions can be made, especially if there is a strong family history of dementia Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living Living independently in the community Visual and auditory acuity adequate for neuropsychological testing Good general health with no diseases expected to interfere with the study Speaks fluent English Ability to provide a reliable study partner All participants are asked to engage in research brain imaging scans, including MRI and PET. Certain surgical implants and/or devices, claustrophobia, or previous high radiation exposure may make you ineligible to participate in brain imaging scans. All in-person visits take place at Northwestern University’s downtown Chicago campus and participants can receive free parking if they park on Northwestern University’s campus. Additional compensation is determined by participation. Please contact the study coordinator for questions. Principal Investigator Vassar, Robert J IRB number STU00023196 More Info Email Study Coordinator Phone 312 908 9339 Copy Study URL to Clipboard Copy
Super Aging Study: Correlates of Active Engagement in Life in the Elderly The purpose of this study is to identify factors that contribute to the maintenance of functioning in old age (age 80 and above). We will be looking at a variety of factors including cognition, personality traits, psychosocial factors, genetic factors, and brain structure. The second purpose of this study is … The purpose of this study is to identify factors that contribute to the maintenance of functioning in old age (age 80 and above). We will be looking at a variety of factors including cognition, personality traits, psychosocial factors, genetic factors, and brain structure. The second purpose of this study is to look at how performance on these variables changes over time. The study consists of a baseline evaluation and follow-up visits every two years. The baseline evaluation consists of nine hours of testing. All visits will take place at our research lab on Northwestern University’s Chicago campus. Testing is split into three different days of three hours each. During the enrollment visit, participants will complete an MRI scan, a blood draw, and neuropsychological testing. We also ask some demographic and health history questions and request that participants fill out surveys and questionnaires. Following study enrollment, participants are required to complete follow up visits every two years which have the same structure as the initial visit. The follow-up evaluations will only total about six hours of testing. Eligibility CriteriaFor individuals with who wish to participate: You must be over the age of 80 and remain actively engaged in life. All participants must be eligible for an MRI scan and willing to come to our Chicago location for each visit. Principal Investigator Weintraub, Sandra IRB number STU00027225 More Info Email Study Coordinator Phone 312 503 2716 Copy Study URL to Clipboard Copy
Alzheimer’s Disease Neuroimaging Initiative 3 The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the … The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the previously funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, and ADNI-2), and remains a public/private collaboration between academia and industry to study biomarkers of AD. ADNI will continue to inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios. This is a non-randomized natural history non-treatment study. Participants will need to be 55 - 90 years, otherwise healthy with no neurologic disease such as Alzheimer's disease. Approximately 1070 - 2000 participants will be enrolled at approximately 59 sites in the United States and Canada. Approximately, 700 - 800 will be rollover participants from previous ADNI studies, and 370 - 1200 will be newly enrolled. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts. Subjects will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years. Eligibility Criteria- No history of major psychiatric disorders such as major depression, bipolar disorder, or schizophrenia. - Must be between the ages of 55-90 years (inclusive). - Must have a study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol. - Must have visual and auditory acuity adequate for neuropsychological testing. - Must be in good general health with no diseases expected to interfere with the study. - For females only: Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile). - Must be willing and able to participate in a longitudinal imaging study lasting up to 5 years. - Must have completed six grades of education or has a good work history (sufficient to exclude mental retardation). - Must speak English fluently. - Must be willing to undergo repeated MRIs (3Tesla) and at least two PET scans - must not have any MRI contraindications (i.e. pacemaker, claustrophobia) - Must agree to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking. - Must agree to collection of blood for biomarker testing. - Must agree to at least one lumbar puncture for the collection of CSF. - Must agree to share genomic data and biomarker samples. Principal Investigator Grant, Ian Michael ClinicalTrials.gov IdentifierNCT02854033IRB number STU00203359 More Info Email Ryan, Caila Ann Phone +1 312 503 3787 Copy Study URL to Clipboard Copy
Longitudinal Early-onset Alzheimer’s Disease Study (LEADS) Join the LEADS Study WaitlistThe Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across two cohorts: (… Join the LEADS Study Waitlist The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across two cohorts: (1) individuals with EOAD and (2) cognitively normal (CN) control participants. The primary objectives of the LEADS study are to: collect longitudinal assessments and biomarker data; to compare baseline and longitudinal cognitive and functional characteristics between cognitively impaired and cognitively normal individuals, and EOAD and Late Onset Alzheimer's Disease (LOAD) individuals from the Alzheimer's Disease Neuroimaging Initiative (ADNI); and to study the associations of longitudinal clinical and cognitive assessments with multimodal imaging and biofluid markers that capture different elements of the AD pathophysiological cascade. Eligibility Criteria Inclusion Criteria (Cognitively Impaired Cohort Only): Diagnosed with MCI due to AD or probable AD dementia Age between 40-64 years (inclusive) Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participant's cognitive and functional performance Principal Investigator Grant, Ian Michael ClinicalTrials.gov IdentifierNCT03507257IRB number STU00207242 More Info Email Ryan, Caila Ann Phone +1 312 503 3787 Copy Study URL to Clipboard Copy
xIRB ALLFTD: ARTFL-LEFFTDS LONGITUDINAL FRONTOTEMPORAL LOBAR DEGENERATION Join the ALLFTD Study WaitlistALLFTD (ARTFL-LEFFTDS Longitudinal Frontotemporal Lobar Degeneration) Study is a comprehensive study targeting most varieties of frontotemporal lobar degeneration (FTLD). FTLD is a neurological disease that causes Frontotemporal Dementia (FTD) syndromes including Primary Progressive Aphasia (PPA) and Behavioral Variant Frontotemporal Dementia (bvFTD), among others. Participating in … Join the ALLFTD Study Waitlist ALLFTD (ARTFL-LEFFTDS Longitudinal Frontotemporal Lobar Degeneration) Study is a comprehensive study targeting most varieties of frontotemporal lobar degeneration (FTLD). FTLD is a neurological disease that causes Frontotemporal Dementia (FTD) syndromes including Primary Progressive Aphasia (PPA) and Behavioral Variant Frontotemporal Dementia (bvFTD), among others. Participating in the longitudinal arm of ALLFTD involves annual visits to an ALLFTD clinical site. Annual visits usually span 2-3 days, and involve a neurological exam; tests of memory, behavior, and judgement; a blood draw, imaging of your brain (MRI), and an optional lumbar puncture (LP). All participants enrolled in ALLFTD will have their DNA (from the blood draw) tested for FTLD-associated genetic mutations, but you do not have to learn this information. Participation may last up to 5 years. The goals of the study are: To identify the best clinical measurements and biomarkers for following patients with FTLD in treatment trials. To identify clinical measurements and biomarkers that indicate when a person with a high risk of developing FTLD due to a mutation will begin to have symptoms. Sharing clinical data, images and biological samples from participants affected by FTLD with the scientific community to address additional scientific questions about FTLD. https://www.allftd.org/ Due to the amazing contributions of our research participants, we have met our site's enrollment goals. If you are interested, we can add you to the ALLFTD waitlist and as sites have availability, we will offer openings to those on our waitlist. If you would like to be placed on our waitlist, please complete this inquiry survey. We strongly encourage you to review additional research opportunities here and we encourage you to join the FTD Disorder Registry Eligibility Criteria ALLFTD includes symptomatic and “at-risk” participants. FTLD may be sporadic, with no known cause. It may also be familial, due to genetic mutations. We are still learning about mutations that cause FTLD, so a strong family history of FTLD is sufficient to enroll as: Familial FTLD (f-FTLD). You are eligible to enroll in the familial FTLD cohort if 1) you have a mutation in one of the three most common genes associated with FTD –microtubule associated protein tau (MAPT), progranulin (GRN), or chromosome 9 open reading frame 72 (C9orf72), regardless of whether you have symptoms or not, 2) you have a blood relative with a mutation in one of those genes, or 3) you have a strong family history of FTLD but no genetic mutation has been identified. Sporadic FTLD (s-FTLD). You are eligible to enroll in the sporadic cohort of the study if you have one of the following FTLD spectrum diagnoses: frontotemporal dementia, primary progressive aphasia, progressive supranuclear palsy, corticobasal degeneration syndrome, or frontotemporal dementia with amyotrophic lateral sclerosis. Principal Investigator Grant, Ian Michael ClinicalTrials.gov IdentifierNCT04363684IRB number STU00211804 More Info Email Ryan, Caila Ann Phone +1 312 503 3787 Copy Study URL to Clipboard Copy
AHEAD 3-45 Study The AHEAD 3-45 Study is closed for enrollment.Alzheimer’s disease (AD) is a progressive, neurodegenerative disorder characterized by cognitive decline with loss of memory. The biological hallmarks of AD include the buildup of an abnormal form of a protein called amyloid, but not every person with amyloid accumulation … The AHEAD 3-45 Study is closed for enrollment. Alzheimer’s disease (AD) is a progressive, neurodegenerative disorder characterized by cognitive decline with loss of memory. The biological hallmarks of AD include the buildup of an abnormal form of a protein called amyloid, but not every person with amyloid accumulation will develop memory problems or AD. Amyloid plaques are composed of β-amyloid peptide (Aβ) and research suggest that Aβ can begin to accumulate 10 to 20 years before the onset of clinical symptoms. “Preclinical AD” is defined as the accumulation of amyloid in the brain, before clinical symptoms. The purpose of the AHEAD study is to determine if an investigational drug (lecanemab) reduces the risk of developing AD dementia through early intervention targeting the amyloid pathway before significant and irreversible neurodegeneration. Lecanemab is a novel humanized immunoglobulin G1 (IgG1) monoclonal antibody that preferentially binds to Aβ protofibrils. This study includes a 216-week treatment period (about 4 years) with an optional open-label extension phase for participants with Preclinical AD. Participants will receive either monthly or bi-weekly depending on their treatment arm (A3 vs. A45). Throughout the study longitudinal cognitive, clinical, safety, fluid biomarker, and imaging biomarker assessments will be performed. https://www.aheadstudy.org/about/ Eligibility Criteria Only individuals aged 55-80 who have intermediate or elevated levels of amyloid in their brain will be able to participate in these studies. The screening process for the AHEAD Study will use a Positron Emission Tomography (PET) scan to measure the level of amyloid in your brain. Must have a study partner that is willing to participate as a source of information and who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, or caregiver). Principal Investigator Lapins, Allison Elizabeth ClinicalTrials.gov IdentifierNCT04468659IRB number STU00212910 More Info Keywords amyloid preclinical Alzheimer's Disease Email Ryan, Caila Ann Phone +1 312 503 3787 Copy Study URL to Clipboard Copy
VIVA MIND Study This study will test an oral investigational drug called varoglutamstat (PQ912) for the treatment of individuals with mild cognitive impairment due to AD or probable mild Alzheimer's Disease. Participation may last up to 20 months. Eligibility Criteria General Inclusion Criteria: Age 50-89 (inclusive) Diagnosed Mild Cognitive Impairment (MCI) due to AD or probable Mild AD Taking (or previously tried) the following Alzheimer’s medication(s) for at least four months: Donepezil (Aricept®) or rivastigmine, (Exelon®) or galantamine (Razadyne®) with or without memantine (Namenda®) Must have a study partner that is willing to participate as a source of information and who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, or caregiver). General Exclusion Criteria: Treatment or plans to receive treatment with any Amyloid Beta Antibody such as aducanumab (Aduhelm) or lecanemab (Leqembi) will exclude you from being eligible for the VIVA MIND Study. https://www.viva-mind.org/ Principal Investigator Grant, Ian Michael ClinicalTrials.gov IdentifierNCT03919162IRB number STU00216590 More Info Email Ryan, Caila Ann Phone +1 312 503 3787 Copy Study URL to Clipboard Copy
Veri-T Study The Veri-T Study will test an oral investigational drug called Verdiperstat (BHV-3241) for the treatment of individuals with Semantic Variant Primary Progressive Aphasia (svPPA). Participation will include cognitive, clinical, safety, fluid biomarker, and imaging assessments for up to 6 months.… The Veri-T Study will test an oral investigational drug called Verdiperstat (BHV-3241) for the treatment of individuals with Semantic Variant Primary Progressive Aphasia (svPPA). Participation will include cognitive, clinical, safety, fluid biomarker, and imaging assessments for up to 6 months. Eligibility Criteria General Inclusion Criteria: Age 18-85 (inclusive) Diagnosed with Semantic Variant Primary Progressive Aphasia (svPPA) Must have a study partner that is willing to participate as a source of information and who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, or caregiver). General Exclusion Criteria: Diagnosis of probable Alzheimer's Disease or any FTLD-associated clinical syndrome other than svPPA will exclude you from being eligible for the Veri-T Study. Principal Investigator Grant, Ian Michael ClinicalTrials.gov IdentifierNCT05184569IRB number STU00216954 More Info Email Ryan, Caila Ann Phone 312 503 5674 Copy Study URL to Clipboard Copy
The ADNI-4 Study is closed for enrollment. The overall goal of ADNI-4 study is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia.This … The overall goal of ADNI-4 study is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. This is a non-randomized natural history non-treatment study. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts: (1) cognitively normal control participants, (2) individuals with mild cognitive impairment and (3) individuals with dementia. Subjects will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (amyloid and tau) and MRI scans and optional cerebral spinal fluid (CSF) collection for up to 5 years. ADNI-4 continues the previously funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, ADNI-2 and ADNI-3), and remains a public/private collaboration between academia and industry to study biomarkers of AD. ADNI will continue to inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios. Since its launch in 2004, the overarching aim of the Alzheimer’s Disease Neuroimaging Initiative (ADNI) has been to validate biomarkers for Alzheimer’s disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. ADNI is an observational research study, which means it has no study drug or intervention. The ADNI study is designed to look at the relationship between clinical, cognitive, imaging, genetic and biomarker tests to learn more about brain health and the full spectrum of Alzheimer’s disease (AD) from its earliest stages. The ADNI study will enroll participants from three groups: • Cognitively Normal (CN) group: individuals with no apparent memory problems • Mild Cognitive Impairment (MCI) group: individuals diagnosed with early or late stages of mild memory problems • Dementia (DEM) group: individuals diagnosed with a mild stage dementia https://www.adni4.org/ Eligibility Criteria Age 55-90 (inclusive) Must have a study partner that is willing to participate as a source of information and who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, or caregiver) No history of major psychiatric disorders such as major depression, bipolar disorder, or schizophrenia. Must have visual and auditory acuity adequate for neuropsychological testing. Must be in good general health with no diseases expected to interfere with the study. Must be willing and able to participate in a longitudinal imaging study lasting up to 5 years. Must speak English fluently. Must be willing to undergo repeated MRIs (3Tesla) and at least two PET scans - must not have any MRI contraindications (i.e. pacemaker, claustrophobia) Must agree to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking. Must agree to collection of blood for biomarker testing. Must agree to share genomic data and biomarker samples. Principal Investigator Grant, Ian Michael ClinicalTrials.gov IdentifierNCT05617014IRB number STU00219227 More Info Email Ryan, Caila Ann Phone +1 312 503 5674 Copy Study URL to Clipboard Copy
Site for Alzheimer’s Plasma Extension (APEX) The Alzheimer’s Plasma Extension Study is an observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years.https://www.actcinfo.org/alzheimers-plasma-extension-apex-study/… The Alzheimer’s Plasma Extension Study is an observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years. https://www.actcinfo.org/alzheimers-plasma-extension-apex-study/ Eligibility Criteria Only individuals who participated in screening for the AHEAD 3-45 Study are eligible to enroll in APEX. The site will contact you directly if you have been determined to be eligible. Principal Investigator Grant, Ian Michael IRB number STU00219392 More Info Email Ryan, Caila Ann Phone +1 312 503 5674 Copy Study URL to Clipboard Copy

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