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Alzheimer’s Research

AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial) (Eisai, Inc./National Institute of Aging (NIA) BAN2401-G000-303) (Protocol #20-14-H-06/Advarra)
1Florida Alzheimer's Disease Research Center (Protocol #20-22-H-07/UofF)
Longitudinal Early-onset Alzheimer's Disease Study (LEADS) (NIA) (Protocol #20-46-H-12/IREx)
Memory Screening Studies on Healthy Aging (Protocol #01-61-H-08)
State of Florida Brain Bank – Searching for the Answers (Protocol #97-82-H-11)
TRC-PAD Program: In-Clinic Trial-Ready Cohort (Protocol #19-38-H-11/Advarra)

AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial) (Eisai, Inc./National Institute of Aging (NIA) BAN2401-G000-303) (Protocol #20-14-H-06/Advarra)

Do you want to participate in a study to determine whether an investigational drug can keep your memory and thinking from declining?

Eisai has a new drug called “lecanemab” (also known as BAN2401)  which targets a harmful substance in your brain, known as amyloid. Amyloid plaques are one of the hallmark features of Alzheimer’s Disease. If lecanemab stops the buildup of these amyloid plaques in your brain, it may help your memory and thinking from declining with age, as occurs with Alzheimer’s Disease.

You may qualify for this study if you are: (1) between 55 and 80 years of age; (2) have “normal” memory and thinking skills; (3) have elevated or intermediate levels of amyloid in the brain during the screening process. The study drug will be given every 2-4 weeks via an intravenous infusion for up to 4 years. Throughout the study, you will have memory and thinking tests, along with MRI scans, and PET scans that show the amount of amyloid and tau (another protein linked to Alzheimer’s Disease) in your brain. You will be reimbursed for your time.

For more information, please call Idaly Velez-Ribe, Ph.D., at (305) 674-2121, ext 55725, or via email at Idaly.VelezUribe2@msmc.com. or Helena Colvee at Helena.ColveeMartin@msmc.com.

1Florida Alzheimer’s Disease Research Center (Protocol #20-22-H-07/UofF)

Do you want to participate in a study which is evaluating the usefulness of brain imaging studies, tests of blood and spinal fluid, together with measurements of memory, thinking, and daily functioning, in the identification of Alzheimer’s disease at an early stage.

The Wien Center, in collaboration with several universities in Florida, is studying how to best use these tests to identify the earliest stages of Alzheimer’s Disease. This study requires a study partner, someone who knows you well and is willing to provide information about changes in your memory and activities of daily living.

You may qualify for this study if you are over 60 years of age and have mild Alzheimer’s Disease, or are over 65 years of age and have normal memory or mild memory loss. During the first year, you will be required to have a PET scan, an MRI scan, a blood draw, a physical and neurological exam, and memory and thinking tests.  In the following years, for as long as the study is funded, you will have annual physical and neurological exams, and tests of your memory and thinking.  You will be reimbursed for your time.

For more information, please contact Kare Velasquez de Lopez at (305) 674-2101, or Karen.VelasquezDeLopez@msmc.com.

Longitudinal Early-onset Alzheimer’s Disease Study (LEADS) (NIA) (Protocol #20-46-H-12/IREx)

Do you want to participate in a study to compare the genetic, biological, and clinical processes between early and late-onset Alzheimer’s Disease (AD)? Much is already known about the more common AD that develops after the age of 65, but little is known about AD that starts before the age of 65, also known as early-onset AD.

You may qualify for this study if you are between the ages of 40 and 64, and have either mild cognitive impairment (MCI) or dementia of mild severity suspected to be caused by Alzheimer’s disease. In addition, you must be fluent in English and have a family member, friend, or caregiver who can provide additional information about your memory and lifestyle.

For up to 4 years, you will have genetic counseling, medical and neurologic exams, cognitive testing, biofluid sample collection (blood and optional spinal fluid samples), and neuroimaging (MRI and PET scans). You will be reimbursed for your time.

For more information, please (305) 674-2037, or contact Joanna Gonzalez, Psy.D., at Joanna.Gonzalez@msmc.com.

Memory Screening Studies on Healthy Aging (Protocol #01-61-H-08)

Are you worried that your memory is not what it used to be? Take advantage of a free memory screening to determine if further evaluation is needed. Participants must be at least 50 years of age. Screenings are available at Mount Sinai Medical Center 4302 Alton Road, #650 Miami Beach, FL 33140.  By appointment only. Please call (305) 674-2037 for more information.

State of Florida Brain Bank – Searching for the Answers (Protocol #97-82-H-11)

Brain Donation is one very important way of confirming the diagnosis of Alzheimer’s disease or other forms of dementia. Brain Donation is crucial for learning more about how to diagnose and treat Alzheimer’s disease. If someone near and dear to you has been diagnosed to have Alzheimer’s disease or memory problems, the State of Florida Brain Bank can make all the arrangements to facilitate the donation of the brain for confirming the diagnosis and for research. Individuals who are in the earliest stages of Alzheimer’s Disease, and those with a pre-Alzheimer condition known as Mild Cognitive Impairment are particularly important for this research. Normal brain tissue, for comparison purposes, is difficult to get but is also very important for research. Individuals who are over the age of 65 and have normal memory can donate their brains for research through this program, after getting a comprehensive neurological examination and an MRI scan of the brain. For those who participate in this study:

At the time of death, we will arrange for the transportation and removal of the brain, at no cost. We will also provide a detailed pathological report, at no cost to you.

If you have any further questions or need more details about this study, please call Cesar Chirinos, Psy.D., at (305) 674-2018 or via email at Cesar.Chirinos@msmc.com or Helena Colvee at Helena.ColveeMartin@msmc.com.

TRC-PAD Program: In-Clinic Trial-Ready Cohort (Protocol #19-38-H-11/Advarra)

Are you over 50 years of age, concerned about your memory, and willing to take part in a future prevention study? If so, you can see if you qualify for this study by visiting a website (www.aptwebstudy.org) and (1) Answer a few questions about family, medical history, and lifestyle factors; and (2) Take your first set of online memory tests (approximately 20 minutes to complete).

If you qualify, you will be eligible to come to the Wien Center where you will have additional tests of memory and thinking, research blood draws, and PET scans to assess your risk of developing Alzheimer’s Disease in the future. If you are at elevated risk, you will be referred to a study designed to prevent AD. If you decide not to join a prevention study, you will have memory tests at the Wien Center every 6 months. You will be reimbursed for your time.

For more information, please (305) 674-2037, or contact Morris Wishnia, MPH, at Morris.Wishnia@msmc.com

Published Research from the Wien Center at Mount Sinai: 2021 to Current

Peer-Review Papers:

  1. Wang WE, Chen R, Mayrand RP, Adjouadi M, Fang R, DeKosky ST, Duara R, Coombes SA, Vaillancourt DE; Alzheimer’s Disease Neuroimaging Initiative. Association of longitudinal cognitive decline with diffusion MRI in Gray Matter, Amyloid, and Tau deposition. Neurobiol Aging. 2023 Jan;121:166-178.
  2. Greig Custo MT, Lang MK, Barker WW, Gonzalez J, Vélez-Uribe I, Arruda F, Conniff J, Rodriguez MJ, Loewenstein DA, Duara R, Adjouadi M, Curiel RE, Rosselli M. The association of depression and apathy with Alzheimer’s disease biomarkers in a cross-cultural sample. Appl Neuropsychol Adult. 2022 Jun 28:1-17.
  3. Moloney CM, Labuzan SA, Crook JE, Siddiqui H, Castanedes-Casey M, Lachner C, Petersen RC, Duara R, Graff-Radford NR, Dickson DW, Mielke MM, Murray ME. Phosphorylated tau sites that are elevated in Alzheimer’s disease fluid biomarkers are visualized in early neurofibrillary tangle maturity levels in the post mortem brain. Alzheimers Dement. 2022 Aug 3. doi: 10.1002/alz.12749
  4. Shojaie M, Cabrerizo M, DeKosky ST, Vaillancourt DE, Loewenstein D, Duara R, Adjouadi M. A transfer learning approach based on gradient boosting machine for diagnosis of Alzheimer’s disease. Front Aging Neurosci. 2022 Oct 5;14:966883. doi: 10.3389/fnagi.2022.966883. 
  5. Moloney CM, Labuzan SA, Crook JE, Siddiqui H, Castanedes-Casey M, Lachner C, Petersen RC, Duara R, Graff-Radford NR, Dickson DW, Mielke MM, Murray ME. Phosphorylated tau sites that are elevated in Alzheimer’s disease fluid biomarkers are visualized in early neurofibrillary tangle maturity levels in the post mortem brain. Alzheimers Dement. 2022 Aug 3. doi: 10.1002/alz.12749.
  6. Rundek T, Del Brutto VJ, Goryawala M, Dong C, Agudelo C, Saporta AS, Merritt S, Camargo C, Ariko T, Loewenstein DA, Duara R, Haq I. Associations Between Vascular Risk Factors and Perivascular Spaces in Adults with Intact Cognition, Mild Cognitive Impairment, and Dementia. J Alzheimers Dis. 2022;89(2):437-448.
  7. Rodriguez MJ, Burke S, Padron D, Duarte A, Rosselli M, Grieg-Custo M, Grudzien A, Loewenstein DA, Duara R. Associations Between Country where Education is Obtained and Cognitive Functioning Among South American and Caribbean Older Adults Living in the U.S. J Cross Cult Gerontol. 2022 Sep;37(3):257-274. doi: 10.1007/s10823-022-09456-0.
  8. Tabarestani S, Eslami M, Cabrerizo M, Curiel RE, Barreto A, Rishe N, Vaillancourt D, DeKosky ST, Loewenstein DA, Duara R, Adjouadi M. A Tensorized Multitask Deep Learning Network for Progression Prediction of Alzheimer’s Disease. Front Aging Neurosci. 2022 May 6;14:810873.
  9. Duara R, Barker W. Heterogeneity in Alzheimer’s Disease Diagnosis and Progression Rates: Implications for Therapeutic Trials. Neurotherapeutics. 2022 Jan;19(1):8-25.
  10. DeKosky ST, Duara R. The Broad Range of Research in Alzheimer’s Disease and Related Dementias. Neurotherapeutics. 2022 Jan;19(1):1-7.
  11. Morar U, Izquierdo W, Martin H, Forouzannezhad P, Zarafshan E, Unger E, Bursac Z, Cabrerizo M, Barreto A, Vaillancourt DE, DeKosky ST, Loewenstein D, Duara R, Adjouadi M. A study of the longitudinal changes in multiple cerebrospinal fluid and volumetric magnetic resonance imaging biomarkers on converter and non-converter Alzheimer’s disease subjects with consideration for their amyloid beta status. Alzheimers Dement (Amst). 2022 Feb 23;14(1):e12258. 
  12. Kurasz AM, Smith GE, Curiel RE, Barker WW, Behar RC, Ramirez A, Armstrong MJ. Patient values in healthcare decision making among diverse older adults. Patient Educ Couns. 2022 May;105(5):1115-1122.
  13. Shojaie M, Tabarestani S, Cabrerizo M, DeKosky ST, Vaillancourt DE, Loewenstein D, Duara R, Adjouadi M. PET Imaging of Tau Pathology and Amyloid-β, and MRI for Alzheimer’s Disease Feature Fusion and Multimodal Classification. J Alzheimers Dis. 2021;84(4):1497-1514.
  14. Crist AM, Hinkle KM, Wang X, Moloney CM, Matchett BJ, Labuzan SA, Frankenhauser I, Azu NO, Liesinger AM, Lesser ER, Serie DJ, Quicksall ZS, Patel TA, Carnwath TP, DeTure M, Tang X, Petersen RC, Duara R, Graff-Radford NR, Allen M, Carrasquillo MM, Li H, Ross OA, Ertekin-Taner N, Dickson DW, Asmann YW, Carter RE, Murray ME. Transcriptomic analysis to identify genes associated with selective hippocampal vulnerability in Alzheimer’s disease. Nat Commun. 2021 Apr 19;12(1):2311.
  15. Kitaigorodsky M, Curiel Cid RE, Crocco E, Gorman KL, González-Jiménez CJ, Greig-Custo M, Barker WW, Duara R, Loewenstein DA. Changes in LASSI-L performance over time among older adults with amnestic MCI and amyloid positivity: A preliminary study. J Psychiatr Res. 2021 Nov;143:98-105.
  16. Kitaigorodsky M, Crocco E, Curiel-Cid RE, Leal G, Zheng D, Eustache MK, Greig-Custo MT, Barker W, Duara R, Loewenstein DA. The relationship of semantic intrusions to different etiological subtypes of MCI and cognitively healthy older adults. Alzheimers Dement (Amst). 2021 May 25;13(1):e12192.
  17. Barker W, Quinonez C, Greig MT, Behar R, Chirinos C, Rodriguez RA, Rosselli M, Rodriguez MJ, Cid RC, Rundek T, McFarland K, Hanson K, Smith G, DeKosky S, Vaillancourt D, Adjouadi M, Marsiske M, Ertekin-Taner N, Golde T, Loewenstein DA, Duara R. Utility of Plasma Neurofilament Light in the 1Florida Alzheimer’s Disease Research Center (ADRC). J Alzheimers Dis. 2021;79(1):59-70.
  18. Arruda F, Rosselli M, Greig MT, Loewenstein DA, Lang M, Torres VL, Vélez-Uribe I, Conniff J, Barker WW, Curiel RE, Adjouadi M, Duara R. The Association Between Functional Assessment and Structural Brain Biomarkers in an Ethnically Diverse Sample With Normal Cognition, Mild Cognitive Impairment, or Dementia. Arch Clin Neuropsychol. 2021 Jan 15;36(1):51-61.
  19. Rouse HJ, Small BJ, Schinka JA, Loewenstein DA, Duara R, Potter H. Mild behavioral impairment as a predictor of cognitive functioning in older adults. Int Psychogeriatr. 2021 Mar;33(3):285-293.
  20. Zheng DD, Curiel Cid RE, Duara R, Kitaigorodsky M, Crocco E, Loewenstein DA. Semantic intrusion errors as a function of age, amyloid, and volumetric loss: a confirmatory path analysis. Int Psychogeriatr. 2021 Jan 18:1-11.
  21. Crocco EA, Curiel Cid R, Kitaigorodsky M, Grau GA, Garcia JM, Duara R, Barker W, Chirinos CL, Rodriguez R, Loewenstein DA. Intrusion Errors and Progression of Cognitive Deficits in Older Adults with Mild Cognitive Impairment and PreMCI States. Dement Geriatr Cogn Disord. 2021 Jun 23:1-8.
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