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| Descriptive Information Fields | |||||
| Brief Title † | Home-Based Assessment for Alzheimer Disease Prevention | ||||
| Official Title † | Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old | ||||
| Brief Summary | The purpose of this study is to evaluate three methods of performing home-based assessments in Alzheimer's Disease (AD) prevention trials. The initial in-person assessment will be done in the clinic or at home. |
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| Detailed Description | There is an unmet need for effective, efficient, and economical methods for conducting AD prevention trials. Traditional in-person visits to clinical assessment sites are time consuming and costly and may exclude some people from participation, such as those who are older, or are less mobile or with significant medical illnesses. These may be the people who are at greatest risk for cognitive decline, and also may be without financial resources for services such as transportation to a study site. Prevention trials require long observation periods and these same issues of health, resources, and transportation may cause significant drop out. These obstacles increase expense of clinical trials which require large sample sizes, costly clinical staff and long observation periods. Thus, home-based assessments may lead to more representative recruitment of those most at risk for decline, as well as better retention and reduced study costs. This is a randomized study of 600 participants, comparing three methods of test administration and data collection. Each enrolled participant will have an In-person (Standard) assessment (in the clinic or at home) prior to baseline. Participants will be classified as either normal or MCI (Mild Cognitive Impairment) and randomly assigned to an assessment method and to a frequency of assessment. Cognitive performance, self-rated cognitive complaint, functioning in daily life, affective symptoms, global change, quality of life and resource use will all be assessed in each method at each visit. The total time for the at-home assessments will be approximately 45 minutes. In addition, all participants will be provided a multi-vitamin to be taken twice a day, and a measure of medication adherence will be collected for each assessment method. Changes in certain cognitive measures may "trigger" an in-person assessment, in which participants may change from a categorization of normal or amnestic MCI, to non-amnestic MCI, impaired not MCI, or dementia (i.e., specifically Alzheimer's Disease or another dementia). We estimate that 12% of the study population will trigger over the 4 years of the study and will progress to a more impaired diagnostic category. In addition, a random sample of non-triggered cases (25%) will be selected for an in-person re-assessment during the 4 years of the protocol as a comparison for the trigger group. At the end of the 4-year study period all participants will undergo an in-person evaluation. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Screening, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained [ Time Frame: 4 years ] [ Designated as safety issue: No ] Efficiency Data -- staff time required to successfully complete data collection [ Time Frame: Each experimental visit ] [ Designated as safety issue: No ] Transition from cognitive health to impairment [ Time Frame: 4 years ] [ Designated as safety issue: No ] Method-Specific Adherence, including medication adherence [ Time Frame: 4 years ] [ Designated as safety issue: No ] Rate of change in domains of assessment [ Time Frame: 4 years ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Research blood samples [ Time Frame: 4 years ] [ Designated as safety issue: No ] Safety Assessments: symptom checklist and adverse event checklist [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] |
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| Condition † | Mild Cognitive Impairment Alzheimer's Disease |
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| Intervention † | Behavioral: Mail and Live Phone Behavioral: Interactive Voice Response (IVR) Behavioral: Home-based Computer Kiosk Behavioral: Traditional Evaluation Instruments |
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| MEDLINE PMIDs | 17135809, 11700161, 11067378, 15746489, 17135810 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 600 | ||||
| Start Date † | September 2007 | ||||
| Completion Date | December 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 75 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00546767 | ||||
| Organization ID | IA0123 | ||||
| Secondary IDs †† | ADC-030-HBA | ||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | Alzheimer's Disease Cooperative Study (ADCS) | ||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | October 11, 2007 | ||||
| Last Updated Date | April 25, 2008 | ||||