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Completed

NCT Number: NCT01867346

Early Markers of Cognitive Change and Alzheimer s Disease

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Identifying early makers of cognitive and Alzheimer s disease

    Time frame: Ongoing

  2. Characterizing risk factors which modify progression to these states

    Time frame: Ongoing

  3. Cognitive changes associated with other health factors

    Time frame: Ongoing

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Collaborators

  • Johns Hopkins University

Registry information

Official study title

Early Markers of Cognitive Change and Alzheimer's Disease: A Propsective Study of the Effects of Aging on Cognition and Brain Pathology

Important dates

Study start
2003
Primary completion
2014
Study completion
2015
First posted
Jun 4, 2013
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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