Implications of Amyloid Pathology

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine whether asymptomatic older individuals with high amyloid burden will subsequently manifest cognitive impairment and eventually progress to clinical Alzheimer's Disease (AD).

Clinical Trial Description

There is compelling evidence supporting amyloid as one of the key pathologic agents in AD. Autopsy studies suggest the amount and location of fibrillar amyloid deposition does not relate strongly to the degree and type of clinical impairment, compared to tau pathology and neuronal loss. A substantial percentage of individuals known to be cognitively intact prior to death demonstrate significant amyloid pathology at autopsy. PIB-PET studies of older normal individuals have also demonstrated significant amyloid deposition in substantial percentages.

This study will test the hypothesis that amyloid is associated with synaptic dysfunction and neuronal damage. While some individuals are able to compensate for amyloid-related toxicity for an extended time period, sensitive imaging and neuropsychological markers will reveal that normal subjects with evidence of high amyloid burden do demonstrate evidence of abnormality consistent with prodromal AD.

The study will use a combination of functional, structural, and cognitive measures to detect early effects of amyloid deposition, and will utilize PIB retention in order to characterize the relationship of amyloid to neuropsychological and imaging markers of prodromal AD. The relationship of PIB retention to genetic, plasma and cerebrospinal fluid (CSF) biomarkers will be explored. These preliminary data will be used to determine whether asymptomatic older individuals with high amyloid burden will subsequently manifest cognitive impairment and eventually progress to clinical AD. When completed, this project will either provide evidence that the presence of amyloid deposition is a useful biomarker for incipient AD or raise the possibility that amyloid deposition examined in isolation is insufficient to predict early symptoms and progression of AD. ;

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00900770
Study type	Observational
Source	National Institute on Aging (NIA)
Contact
Status	Recruiting
Phase	N/A
Start date	November 2008
Completion date	March 2014

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	`NCT02580305` - SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study	Phase 2
Completed	`NCT02516046` - 18F-AV-1451 Autopsy Study	Phase 3
Terminated	`NCT02521558` - Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease	N/A
Recruiting	`NCT02247180` - Cognitive Rehabilitation in Alzheimer`s Disease	N/A
Completed	`NCT02317523` - Alzheimer's Caregiver Coping: Mental and Physical Health	N/A
Completed	`NCT02260167` - Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol	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
Not yet recruiting	`NCT01940952` - Zydena on Cognitive Function of Alzheimer's Disease Patients	Phase 3

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.