Northwestern University Feinberg School of Medicine

Mesulam Cognitive Neurology and Alzheimer’s Disease Center

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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Coventry, Christina Ann 1 312 908 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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Riley, Michaela 312 503 5103
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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Makowski-Woidan, Beth 312 503 2716
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
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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Riley, Michaela 312 503 5103
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 …
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.
- 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.
Rogalski, Emily JoyRogalski, Emily Joy
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02854033 STU00203359
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Robson, Jordan 312 503 5212
Long-Term Nicotine Treatment of Mild Cognitive Impairment
The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with Mild Cognitive Impairment (MCI). Neuronal nicotinic receptors have long been …
The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with Mild Cognitive Impairment (MCI). Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function. The study will enroll participants for a 2 year period. Participants will be randomized (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day, or placebo skin patch.
Inclusion Criteria:
1. Subject must have a subjective memory concern as reported by subject, study partner, or clinician
2. Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised:
- less than or equal to 11 for 16 or more years of education
- less than or equal to 9 for 8 - 15 years of education
- less than or equal to 6 for 0 - 7 years of education
3. Mini-Mental State Exam score between 24 and 30, inclusive
4. Clinical Dementia Rating (CDR) Global = 0.5. Memory Box score must be at least 0.5
5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease dementia cannot be made by the site physician at the time of the screening visit
6. Age 55-90 (inclusive)
7. Stable permitted medications for 4 weeks or longer as specified in Section 6, including: • Memantine is allowable if stable for 12 weeks prior to screen
8. No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4
9. Geriatric Depression Scale score of less than or equal to 9
10. Study Partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to most visits to answer questions about the subject
11. Adequate visual and auditory acuity to allow neuropsychological testing
12. Good general health with no additional diseases/disorders expected to interfere with the study
13. ECG without clinically significant abnormalities that would be expected to interfere with study participation
14. Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
15. Completed six grades of education or has a good work history
16 Must speak English fluently
Exclusion Criteria:

1. Regular use of tobacco products within the past year, such as smoking (cigarettes, pipes, cigars, etc.) or use of other nicotine products (chewing tobacco, e-cigarettes, nicotine patches, gum, sprays, etc.).
2. Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
3. Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol
4. History of schizophrenia (DSM V criteria)
5. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
6. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
7. Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
8. Clinically significant abnormalities in B12 or TFTs (Thyroid Function Tests) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
9. Clinically significant abnormalities in screening laboratories or ECG.
10. Residence in skilled nursing facility.
11. Use of any excluded medication as described in the protocol, including:
12. Use of cholinesterase inhibitors or centrally acting cholinergic drugs
13. Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
14. For CSF sub-study participants, a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT (partial thromboplastin time) at screening
15. For MRI sub-study participants, contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.
16. Patients whom the Site PI deems to be otherwise ineligible.
Grant, IanGrant, Ian
  • Map it 676 N. St. Clair St. Suite 945
    Chicago, IL
NCT02720445 STU00204222
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Robson, Jordan 312 503 5212