Clinical Trials

Trials
Language in Primary Progressive Aphasia
The Language in Primary Progressive Aphasia (PPA) aims to understand the behavioral, anatomical and physiological changes in people with PPA throughout the course of the illness. The researchers in this study want to increase awareness of PPA, educate others ab…
The Language in Primary Progressive Aphasia (PPA) aims to understand the behavioral, anatomical and physiological changes in people with PPA throughout the course of the illness. The researchers in this study want to increase awareness of PPA, educate others about this unique disorder, and to encourage more research to eventually develop therapies. During the three-day research program, participants will be asked to undergo neuropsychological testing (paper and pencil tests that evaluate cognition), an MRI (a non-invasive brain-imaging procedure), an EEG (another non-invasive procedure that looks at brain waves when you think) and other computer and language testing batteries. Participants may be asked to return every two years to complete the same measures. The study will recruit approximately 15 participants with PPA per year. For participants not living near Chicago, IL, flights and accommodations (for both the person with PPA and their companion) will be covered by the study.
For individuals with who wish to participate:

You 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.
Mesulam, Marek-MarselMesulam, Marek-Marsel
NCT00537004 STU00026372
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Rader, Benjamin 312 908 9681
Alzheimer's Disease Core Center
The Northwestern Alzheimer’s Disease Center (NADC) was established with funding from the National Institute on Aging (NIA) in 1996. The primary goals of the center are to 1) provide state-of-the-art care to patients with Alzheimer’s disease and related disorders, …
The Northwestern Alzheimer’s Disease Center (NADC) was established with funding from the National Institute on Aging (NIA) in 1996. The primary goals of the center are to 1) provide state-of-the-art care to patients with Alzheimer’s disease and related disorders, and 2) support clinical and basic research on memory and aging through the collection and storage of clinical data and brain tissue from research participants. Clinical data and tissue are distributed to collaborators throughout Northwestern, as well as to other Alzheimer Disease Centers. The NADC is comprised of five Cores: Clinical, Administrative, Neuropathology, Data Management and Biostatistics, and Education. Over the past year, the Clinical and Data cores have worked closely with the Education and Neuropathology cores to recruit and enroll subjects, facilitate brain donations, support investigations of dementia and aging, and educate the public on effectively coping with these illnesses.
For individuals with dementia who wish to participate in studies:

You must carry a diagnosis of mild cognitive impairment, Alzheimer's disease or other dementia (frontotemporal dementia, primary progressive aphasia, Lewy Body disease and others), established a thorough evaluation prior to enrollment to assure that individuals are eligible to participate. 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.

For older individuals without meaningful cognitive decline who wish to participate in studies:
Must meet screening criteria which exclude illnesses that could interfere with cognitive function, and be able to provide the name of a friend or family member who can answer questions about daily activities and whether or not there are observable symptoms of forgetfulness.
Mesulam, Marek-MarselMesulam, Marek-Marsel
STU00023196
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Martindale, Laura 312 926 1851
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 …
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.
For 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.
Rogalski, Emily JoyRogalski, Emily Joy
STU00027225
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Loyer, Emmaleigh 312 503 2716
Alzheimer's Disease Neuroimaging Initiative 2
The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Reco…
The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the neuroscience of AD. This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.
Rogalski, Emily JoyRogalski, Emily Joy
NCT01231971 STU00038190
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Lipowski, Kristine Lynn 312 503 2486
Communication Bridge: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
The purpose of this study is to evaluate the effectiveness of speech and language therapy on individuals diagnosed with Primary Progressive Aphasia (PPA) ability to communicate immediately after tr…
The purpose of this study is to evaluate the effectiveness of speech and language therapy on individuals diagnosed with Primary Progressive Aphasia (PPA) ability to communicate immediately after treatment, 6-months after treatment. We additionally hope to identify the most effective speech and language therapy strategies for persons with these conditions. Lastly, we hope to determine the feasibility of Internet-based video-practice of speech and language therapy for persons with these conditions. The study will involve 11 to 14 session over the course of 6 months. These sessions will all take place over the Internet, using an online study portal.
For individuals with who wish to participate: You 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 and care-partner to be comfortable using computers and videoconferencing software. Care-partners of patients must be available to participate for all speech-language therapy sessions and evaluations.
Rogalski, Emily JoyRogalski, Emily Joy
NCT02439853 STU00073634
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Saxon, Marie 312 503 4012
The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF)
An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can arrest or reverse the disease at its earliest stages. The emotional and financial burden of AD to patients, family…
An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can arrest or reverse the disease at its earliest stages. The emotional and financial burden of AD to patients, family members, and society is enormous, and is predicted to grow exponentially as the median population age increases. Current FDA-approved therapies are modestly effective at best. This study will examine a novel therapeutic approach using intranasal insulin (INI) that has shown promise in short-term clinical trials. If successful, information gained from the study has the potential to move INI forward rapidly as a therapy for AD. The study will also provide evidence for the mechanisms through which INI may produce benefits by examining key cerebral spinal fluid (CSF) biomarkers and hippocampal/entorhinal atrophy. These results will have considerable clinical and scientific significance, and provide therapeutically-relevant knowledge about insulin's effects on AD pathophysiology. Growing evidence has shown that insulin carries out multiple functions in the brain, and that insulin dysregulation may contribute to AD pathogenesis. This study will examine the effects of intranasally-administered insulin on cognition, entorhinal cortex and hippocampal atrophy, and cerebrospinal fluid (CSF) biomarkers in amnestic mild cognitive impairment (aMCI) or mild AD. It is hypothesized that after 12 months of treatment with INI compared to placebo, subjects will improve performance on a global measure of cognition, on a memory composite and on daily function. In addition to the examination of CSF biomarkers and hippocampal and entorhinal atrophy, the study aims to examine whether baseline AD biomarker profile, gender, or Apolipoprotein epsilon 4 (APOE-ε4) allele carriage predict treatment response. In this study, 240 people with aMCI or AD will be given either INI or placebo for 12 months, following an open-label period of 6 months where all participants will be given active drug. The study uses insulin as a therapeutic agent and intranasal administration focusing on nose to brain transport as a mode of delivery.
Mesulam, Marek-MarselMesulam, Marek-Marsel
NCT01767909 STU00085066
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Robson, Jordan 312 503 5212
Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
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 called solanezumab, an anti-amyloid antibody, can slow mem…
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 called solanezumab, an anti-amyloid antibody, can slow memory loss caused by Alzheimer’s disease. Amyloid is a protein normally produced in the brain that can build up in older people, forming amyloid plaque deposits. Scientists believe this buildup of deposits may play a key role in the eventual development of Alzheimer’s disease-related memory loss. 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 invites healthy older individuals (ages 65-85) who have normal thinking and memory function but who may be at risk for memory loss due to Alzheimer’s disease, but have no outward signs of the disease to participate in the study.
- Are 65 to 85 years old
- Have normal thinking and memory abilities
- Have an A4 study partner – someone who has at least weekly contact (at least 10 hours) with you who can answer questions once a year
- Are willing and able to receive monthly infusions of the investigational treatment or placebo for 3 years - Are willing and able to participate in all required procedures for the duration of the A4 study.
- Are willing to have your health monitored throughout the study using assessments such as:
(1) Memory and thinking tests
(2) ECGs (a look at your heart)
(3) PET scan (a way to look for the plaques thought to be associated with AD)
(4) MRI scans (a way to take a picture of your brain)
(5) Blood and urine tests
Weintraub, SandraWeintraub, Sandra
NCT02008357 STU00087736
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Robson, Jordan 1-888-NU-STUDY
Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotem…
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is to build a FTLD clinical research consortium to support the development of FTLD therapies for new clinical trials. The consortium, referred to as Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner with six patient advocacy groups to manage the consortium. Participants will be evaluated at 14 clinical sites throughout North America and a genetics core will genotype all individuals for FTLD associated genes.
1. Between 18 and 85 (inclusive) years of age.
2. Able to walk (with assistance) at the time of enrollment.
3. Have a reliable study partner who can provide an independent evaluation of functioning.
4. Speak English or Spanish.
5. Meet the clinical diagnostic criteria for PSP, semantic PPA, CBS, vFTD, FTD-ALS, or non-fluent PPA.
Weintraub, SandraWeintraub, Sandra
NCT02365922 STU00200202
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Martindale, Laura 312 503 5103
A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease
AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment for malignancies because these kinases play a role in tumor invasion and proliferation. However, th…
AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment for malignancies because these kinases play a role in tumor invasion and proliferation. However, the Src family kinases (SFKs) are highly expressed in brain and have major effects on synaptic plasticity. Moreover, the investigators have recently shown that a specific SFK, namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß) peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in preclinical models. This clinical trial will test the potential benefit of AZD0530 for Alzheimer's disease modification.
Bonakdarpour, BornaBonakdarpour, Borna
NCT02167256 STU00200256
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Lipowski, Kristine Lynn 312 503 5212
Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study
The LEARN study a multicenter, observational study will that will evaluate the rate of cognitive change in approximately 500 clinically normal older individuals who "screen-fail" for the A4 trial on the basis of their scr…
The LEARN study a multicenter, observational study will that will evaluate the rate of cognitive change in approximately 500 clinically normal older individuals who "screen-fail" for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility criteria. This study will leverage the A4 infrastructure and maximize the data acquired in screening a large number of well-characterized older adults for the A4 trial. The LEARN observational cohort will provide a critical comparison group for the A4 placebo arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it is important to demonstrate a differential rate of clinical decline between Aβe ("Aβ elevated") and Aβne ("Aβ not elevated") individuals on a standardized set of clinical outcomes. Over 2000 well-characterized, highly motivated older volunteers will "screen fail" for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely as possible to the two treatment arms, in this observation cohort. The LEARN study may selectively recruit from a specific range of SUVr that fall below the threshold for "elevated amyloid" in order to support analyses of the relationship of baseline SUVr to subsequent cognitive change and amyloid accumulation. The observational cohort will be followed for 168 weeks with identical clinical/cognitive testing performed every 24 weeks, running parallel to the A4 treatment study.
Weintraub, SandraWeintraub, Sandra
NCT02488720 STU00200681
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Lipowski, Kristine Lynn 312 503 2486