Alzheimer's DiseaseNCT01867346
Early Markers of Cognitive Change and Alzheimer s Disease
An observational study of Alzheimer's Disease, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 2,850 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2003to 2 Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All BLSA participants 60 years of age and older are included and will receive cognitive evaluations on their BLSA visits.
Who cannot join
- Participants who are younger than 60 years old are excluded. Specialized testing procedures are adopted in the case of hearing or visual impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
Official title: Early Markers of Cognitive Change and Alzheimer's Disease: A Propsective Study of the Effects of Aging on Cognition and Brain Pathology
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.
Read more
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Keywords
- Cognition, Aging, Cognitive Decline, Dementia, Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying early makers of cognitive and Alzheimer s disease
Measured: Ongoing
Characterizing risk factors which modify progression to these states
Measured: Ongoing
Cognitive changes associated with other health factors
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start19 Mar 2003
- Primary completion16 Jun 2014
- Study completion2 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Alan B Zonderman, Ph.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867346
- Sponsor's protocol ID
- 999903323
- Other IDs
- 03-AG-N323
- Status last verified
- 2 Jan 2015
- First submitted
- 29 May 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Lindeman RD, Tobin JD, Shock NW. Association between blood pressure and the rate of decline in renal function with age. Kidney Int. 1984 Dec;26(6):861-8. doi: 10.1038/ki.1984.229.
PubMed 6533397Zonderman AB, Giambra LM, Arenberg D, Resnick SM, Costa PT Jr, Kawas CH. Changes in immediate visual memory predict cognitive impairment. Arch Clin Neuropsychol. 1995 Mar;10(2):111-23.
PubMed 14589733Troncoso JC, Martin LJ, Dal Forno G, Kawas CH. Neuropathology in controls and demented subjects from the Baltimore Longitudinal Study of Aging. Neurobiol Aging. 1996 May-Jun;17(3):365-71. doi: 10.1016/0197-4580(96)00028-0.
PubMed 8725897
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Markers of Cognitive Change and Alzheimer's Disease: A Propsective Study of the Effects of Aging on Cognition and Brain Pathology
- ClinicalTrials.gov ID
- NCT01867346
- Acronym / sponsor ID
- 999903323
- Conditions
- Alzheimer's Disease
- Keywords
- Cognition, Aging, Cognitive Decline, Dementia, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,850 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Study start
- 19 Mar 2003
- Primary completion
- 16 Jun 2014 (actual)
- Study completion
- 2 Jan 2015
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All BLSA participants 60 years of age and older are included and will receive cognitive evaluations on their BLSA visits.
Key exclusion criteria (1 listed)
- Participants who are younger than 60 years old are excluded. Specialized testing procedures are adopted in the case of hearing or visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying early makers of cognitive and Alzheimer s disease
Time frame: Ongoing
Characterizing risk factors which modify progression to these states
Time frame: Ongoing
Cognitive changes associated with other health factors
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 6533397Lindeman RD, Tobin JD, Shock NW. Association between blood pressure and the rate of decline in renal function with age. Kidney Int. 1984 Dec;26(6):861-8. doi: 10.1038/ki.1984.229.
- Background: PubMed 14589733Zonderman AB, Giambra LM, Arenberg D, Resnick SM, Costa PT Jr, Kawas CH. Changes in immediate visual memory predict cognitive impairment. Arch Clin Neuropsychol. 1995 Mar;10(2):111-23.
- Background: PubMed 8725897Troncoso JC, Martin LJ, Dal Forno G, Kawas CH. Neuropathology in controls and demented subjects from the Baltimore Longitudinal Study of Aging. Neurobiol Aging. 1996 May-Jun;17(3):365-71. doi: 10.1016/0197-4580(96)00028-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan B Zonderman, Ph.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying early makers of cognitive and Alzheimer s disease (time frame: Ongoing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867346, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.