Biomarkers & Early Alzheimer's Disease

Status Recruiting

Clinical Trial Summary

The main goal of this project is to use imaging and biomarkers to identify cognitively normal elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease (AD). The second goal of this project is to describe the inter-relationships among anatomical biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people who develop MCI.

Clinical Trial Description

The goal of this project is to use magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) biomarkers to identify cognitively normal participants who show the earliest clinically detectable brain changes of Alzheimer's disease (AD).

The major hypothesis for this study is that CSF P-tau231 measurement improves the accuracy of MRI and cerebrospinal fluid (CSF) measurements in predicting mild cognitive impairment (MCI). Validation of this hypothesis can lead to improved diagnostic tools for detecting AD as early as possible.

This 5-year longitudinal study will involve a baseline exam and two 18-month followup exams. Participants will undergo MRI scans, CSF collection and blood samples, neuropsychological performance testing, and medical, neurological and psychiatric assessment. The screening and diagnostic evaluations will be carried out by the New York University Alzheimer Disease Core Center (ADCC) and the NYU Center for Brain Health.

This study will enroll a minimum of 80 cognitively normal participants, 60 to 80 years of age, with English as their first language, with about 12 years of formal education, and who are living in the metropolitan New York City area. All participants will receive baseline and follow-up evaluations to rule out confounding medical, neurological, and psychiatric conditions that could affect cognition. The study coordinator will maintain 6-month telephone contact with all participants and their caregivers who are part of the project. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00094952
Study type	Observational
Source	National Institute on Aging (NIA)
Contact	Kenneth E. Rich
Phone	212-263-7563
Email	kenneth.rich@med.nyu.edu
Status	Recruiting
Phase	N/A
Start date	April 2003
Completion date	March 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05040048` - Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
Withdrawn	`NCT03316898` - A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease	Phase 1
Withdrawn	`NCT02860065` - CPC-201 Alzheimer's Disease Type Dementia: PET Study	Phase 2
Completed	`NCT01315639` - New Biomarker for Alzheimer's Disease Diagnostic	N/A
Not yet recruiting	`NCT03740178` - Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)	Phase 1
Recruiting	`NCT05607615` - A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease	Phase 2
Terminated	`NCT03307993` - Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease	Phase 1
Recruiting	`NCT02912936` - A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease	N/A
Active, not recruiting	`NCT02899091` - Evaluation of the Safety and Potential Therapeutic Effects of CB-AC-02 in Patients With Alzheimer's Disease	Phase 1/Phase 2
Completed	`NCT02907567` - Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease	Phase 1/Phase 2
Not yet recruiting	`NCT02868905` - Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women	N/A
Completed	`NCT02516046` - 18F-AV-1451 Autopsy Study	Phase 3
Terminated	`NCT02521558` - Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease	N/A
Completed	`NCT02580305` - SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study	Phase 2
Recruiting	`NCT02247180` - Cognitive Rehabilitation in Alzheimer`s Disease	N/A
Completed	`NCT02317523` - Alzheimer's Caregiver Coping: Mental and Physical Health	N/A
Terminated	`NCT02220738` - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors	Phase 1
Completed	`NCT02256306` - The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study	N/A
Completed	`NCT02260167` - Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol	N/A
Withdrawn	`NCT01636596` - Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Biomarkers and Early Alzheimer's Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms