Early Markers of Cognitive Change and Alzheimer s Disease

This study is currently recruiting participants.
Verified November 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT01867346
First received: May 29, 2013
Last updated: March 14, 2014
Last verified: November 2012
  Purpose

Background:

- The Baltimore Longitudinal Study of Aging (BLSA) is a long-term study of human aging. To see how the brain changes with age, researchers will study BLSA participants who are at least 60 years old. In particular, researchers are looking for early markers of possible Alzheimer's disease and other conditions that cause memory loss. To do so, they will give tests of memory and brain function, and stay in close contact with participants.

Objectives:

- To study cognitive changes that occur in normal aging and in people who develop memory problems.

Eligibility:

- Individuals at least 60 years of age who are participating in the BLSA.

Design:

  • There are three parts to this study. These study procedures will be done under the usual BLSA guidelines.
  • Participants will take paper and pencil tests. The tests measure skills such as language, attention, memory, and problem solving. They will also ask questions about emotions and feelings.
  • Participants will give the name and phone number of a person who knows them well and sees them often. Researchers will ask this person to fill out questionnaires on the effects of aging on the participant. These questions will monitor the participant's memory and ability to function independently.
  • Participants will have regular phone calls between study visits. These calls will help to keep their information up to date.
  • Participants will continue on this study for as long as they are able to participate.

Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Early Markers of Cognitive Change and Alzheimer's Disease: A Propsective Study of the Effects of Aging on Cognition and Brain Pathology

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Identifying early makers of cognitive and Alzheimer s disease [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Characterizing risk factors which modify progression to these states [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Cognitive changes associated with other health factors [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: March 2003
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Since the early 1960 s cognitive testing has been performed in conjunction with BLSA visits.

Prior to the mid-1980 s, the primary focus of these investigations was the natural history of age associated changes in memory and other cognitive functions. While a portion of the work of the Cognition Section still involves descriptive studies of cross-sectional and longitudinal effects of age on specific cognitive abilities, the cognitive testing program was refocused in the mid-1980 s to investigate early predictors of cognitive change, including risk and protective factors for cognitive impairment and Alzheimer s disease. In collaboration with Dr. Claudia Kawas, and more recently Dr. Richard O Brien of the Johns Hopkins Department of Neurology, the research program of the Cognition Section was expanded to ascertain incident cases of cognitive impairment and dementia, including home visit assessments for inactive participants. In addition, an autopsy program in collaboration with the Alzheimer s Disease Research Center (ADRC) at Johns Hopkins University was initiated. This collaboration has yielded a number of important findings including information on the incidence of Alzheimer s disease, and demonstrations that use of hormone replacement therapy in postmenopausal women and non-steroidal antiinflammatory drugs (NSAIDs) in older adults6 are associated with reductions in the risk for Alzheimer s disease in our community-dwelling BLSA participant sample.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

All BLSA participants 60 years of age and older are included and will receive cognitive evaluations on their BLSA visits.

EXCLUSION CRITERIA:

Participants who are younger than 60 years old are excluded. Specialized testing procedures are adopted in the case of hearing or visual impairments

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867346

Contacts
Contact: Alan B Zonderman, Ph.D. (410) 558-8280 zondermana@mail.nih.gov

Locations
United States, Maryland
National Institute of Aging, Clinical Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Alan B Zonderman, Ph.D. National Institute on Aging (NIA)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT01867346     History of Changes
Other Study ID Numbers: 999903323, 03-AG-N323
Study First Received: May 29, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cognition
Aging
Cognitive Decline
Dementia
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014