Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
170 participants
OBSERVATIONAL
2003-09-30
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will collect neuropsychological data, magnetic resonance imaging (MRI), and cerebrospinal fluid (CSF) from volunteer participants to measure the relationship between changes in brain volume, CSF levels, and memory performance.
From the data researchers hope to develop an early diagnostic test for AD.
The study will include 170 participants between the ages of 60 and 80 years, some normal, some with MCI, some with mild AD, and some with frontotemporal dementia. After initial screening of volunteers, the researchers will give participants a complete baseline exam and 24-month follow-up exams over a period of five years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Residents of the New York City metropolitan area.
* Minimum of 12 years of education.
* Participants will be grouped according to the following classifications: normal aging, mild cognitive impairment (MCI), Alzheimer's disease (AD), or frontotemporal dementia (FTD).
* Participants will agree to ApoE genotyping and DNA banking.
Exclusion Criteria
* Significant history of alcoholism or drug abuse.
* History of psychiatric illness (e.g., schizophrenia, mania or depression).
* Any focal signs or significant neuropathology.
* A score of 4 or greater on the Modified Hachinski Ischemia Scale suggesting cerebrovascular disease.
* A total score of 16 or more on the Hamilton Depression Scale to exclude possible cases of primary depression.
* Evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions.
* Physical impairment of such severity as to adversely affect the validity of psychological testing.
* Hostility or refusal to cooperate.
* Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during MRI imaging.
* History of familial early onset dementia.
60 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mony J. de Leon, Ed.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Brain Health, Silberstein Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Brain Health, Silberstein Institute, New York University School of Medicine
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kenneth E. Rich
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
de Leon MJ, Segal S, Tarshish CY, DeSanti S, Zinkowski R, Mehta PD, Convit A, Caraos C, Rusinek H, Tsui W, Saint Louis LA, DeBernardis J, Kerkman D, Qadri F, Gary A, Lesbre P, Wisniewski T, Poirier J, Davies P. Longitudinal cerebrospinal fluid tau load increases in mild cognitive impairment. Neurosci Lett. 2002 Nov 29;333(3):183-6. doi: 10.1016/s0304-3940(02)01038-8.
Buerger K, Teipel SJ, Zinkowski R, Blennow K, Arai H, Engel R, Hofmann-Kiefer K, McCulloch C, Ptok U, Heun R, Andreasen N, DeBernardis J, Kerkman D, Moeller H, Davies P, Hampel H. CSF tau protein phosphorylated at threonine 231 correlates with cognitive decline in MCI subjects. Neurology. 2002 Aug 27;59(4):627-9. doi: 10.1212/wnl.59.4.627.
Mehta PD, Pirttila T, Mehta SP, Sersen EA, Aisen PS, Wisniewski HM. Plasma and cerebrospinal fluid levels of amyloid beta proteins 1-40 and 1-42 in Alzheimer disease. Arch Neurol. 2000 Jan;57(1):100-5. doi: 10.1001/archneur.57.1.100.
Haghdel A, Smith N, Glodzik L, Li Y, Wang X, Crowder T, Zhu YS, Butler T, Blennow K, McIntire LB, Pahlajani S, Osborne J, Chiang G, de Leon M, Ivanidze J. Evidence of Pericyte Damage in a Cognitively Normal Cohort: Association With CSF and PET Biomarkers of Alzheimer Disease. Alzheimer Dis Assoc Disord. 2024 Apr-Jun 01;38(2):107-111. doi: 10.1097/WAD.0000000000000623. Epub 2024 May 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IA0056
Identifier Type: -
Identifier Source: org_study_id