Mild Cognitive ImpairmentHBANCT00546767
Home-Based Assessment for Alzheimer Disease Prevention
A study testing Mail and Live Phone, Interactive Voice Response (IVR) and Home-based Computer Kiosk in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 28 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Mail and Live Phone, Interactive Voice Response (IVR) and Home-based Computer Kiosk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 28 sitesUnited States
- Study dates
- Sep 2007to Jun 2013
- Phase
- Interventional
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 75 and older
- Willing to sign consent
- Willing to take multi-vitamins provided by the study
- Minimal computer skills or willingness to learn (as demonstrated by completion during screening of a demonstration module for each arm)
- English fluency
- MMSE greater than 26
Show all 11Show fewer
- Able to answer and dial a telephone
- Able to complete the in-person assessment
- Able to complete the computerized assessment including adequate speech, hearing and vision
- Independently living adults, defined as living in a setting in which the participant can ensure access to the resources for study procedures
- Participation of a study partner is desirable and encouraged, but not required
Who cannot join
- Dementia
- Use of prescription cognitive-enhancing drugs at entry (e.g. Aricept, Razadyne, Exelon, Namenda)
- Intent to continue use of own multi-vitamins (for the duration of the study participants must agree to take only study-distributed multi-vitamins)
- History or presence of major psychiatric, neurological or neurodegenerative conditions associated with significant cognitive impairment such as major stroke, Parkinson's disease, Multiple Sclerosis or Huntington's disease. Transient Ischemic Attack (TIA) is acceptable if over 6 months ago
- Medical conditions associated with life expectancy of less than 5 years
- Transient domicile interfering with ability to collect study-related data
- Current participation in a clinical trial involving Central Nervous System (CNS) medications or cognitive testing that would interfere with the current protocol (participation in Uniform Data Set (UDS) assessments by an ADC is permitted)
- Cohabitation with another participant in this particular study
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
University of Michigan Psychiatry - Neuropsychology
Ann Arbor, Michigan, 48105
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston University Alzheimer's Disease Clinical and Research Program
Boston, Massachusetts, 02118
Northwestern University Cognitive Neurology & Alzheimer's Disease
Chicago, Illinois, 60611
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612
Case Western Reserve University
Cleveland, Ohio, 44120
The Ohio State University
Columbus, Ohio, 43210
Indiana University
Indianapolis, Indiana, 46202
University of California, Irvine Institute for Brain Aging and Dementia
Irvine, California, 92697
Mayo Clinic Jacksonville Neurology
Jacksonville, Florida, 32224
University of California-San Diego ADRC/Neurosciences
La Jolla, California, 92037
University of Nevada School of Medicine
Las Vegas, Nevada, 89102
University of Kentucky Sanders-Brown Center on Aging
Lexington, Kentucky, 40536
University of California, Davis
Martinez, California, 94553
Wien Center
Miami Beach, Florida, 33140
Yale University Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510
New York University Aging and Dementia Research Center
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Stanford University / PAIRE
Palo Alto, California, 94304
University of Pennsylvania Geriatrics
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
University of Utah Center for Alzheimer's Care
Salt Lake City, Utah, 84108
Sun Health Reseach Institute
Sun City, Arizona, 85351
Neurological Care of CNY
Syracuse, New York, 13210
University of South Florida, Suncoast Alzheimer's & Gerontology Center
Tampa, Florida, 33617
Georgetown University
Washington D.C., District of Columbia, 20057
Wake Forest University Gerontology and Geriatric Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Mail and Live Phone, Interactive Voice Response (IVR), Home-based Computer Kiosk, Traditional Evaluation Instruments
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mail and Live PhoneBehavioural
This group will receive assessments of all domains by mail, except for the cognitive performance assessment which will be administered via phone by a live, trained evaluator. Medication compliance will be monitored by a written medication log which will be returned by mail with the other mail-in assessments.
Interactive Voice Response (IVR)Behavioural
In this group, participants will be asked to answer questions via an automated phone system using interactive voice recognition (IVR) and key-pad response entry. Medication compliance will be monitored by the same method. A standard large-key telephone and training in the use of the interactive phone system will be provided to all participants.
Home-based Computer KioskBehavioural
Participants at entry will receive a special Kiosk-like device for collecting assessment information and will be taught to use this device. The user interface will consist of a monitor with a touch screen and a telephone handset, similar to what is often used in museum displays. Pre-recorded instructions will be delivered through the handset as well as displayed visually on the screen. Data will be collected using the handset's high-quality microphone. Daily activity assessments of timed medication use will be obtained via an automated medication tracking device.
Traditional Evaluation InstrumentsBehavioural
Evaluation methods typically used in clinical trials
| Study group | Role | What they receive |
|---|---|---|
| Mail and Live Phone | Experimental | Not described Receives: Behavioral: Mail and Live Phone |
| IVR | Experimental | Not described Receives: Behavioral: Interactive Voice Response (IVR) |
| Computer Kiosk | Experimental | Not described Receives: Behavioral: Home-based Computer Kiosk |
| Traditional | Active comparator | Not described Receives: Behavioral: Traditional Evaluation Instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained
Measured: 4 years
Efficiency Data -- staff time required to successfully complete data collection
Measured: Each experimental visit
Transition from cognitive health to impairment
Measured: 4 years
Method-Specific Adherence, including medication adherence
Measured: 4 years
Rate of change in domains of assessment
Measured: 4 years
Secondary outcomes (2)
Research blood samples
Measured: 4 years
Safety Assessments: symptom checklist and adverse event checklist
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mary Sano, PhD, Principal investigator, Mount Sinai Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546767
- Sponsor's protocol ID
- IA0123
- Other IDs
- 1RC2AG036535, ADC-030-HBA
- Acronym
- HBA
- Status last verified
- Sep 2014
- First submitted
- 11 Oct 2007
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Galasko D, Bennett DA, Sano M, Marson D, Kaye J, Edland SD; Alzheimer's Disease Cooperative Study. ADCS Prevention Instrument Project: assessment of instrumental activities of daily living for community-dwelling elderly individuals in dementia prevention clinical trials. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S152-69. doi: 10.1097/01.wad.0000213873.25053.2b.
PubMed 17135809Mundt JC, Ferber KL, Rizzo M, Greist JH. Computer-automated dementia screening using a touch-tone telephone. Arch Intern Med. 2001 Nov 12;161(20):2481-7. doi: 10.1001/archinte.161.20.2481.
PubMed 11700161Piette JD. Interactive voice response systems in the diagnosis and management of chronic disease. Am J Manag Care. 2000 Jul;6(7):817-27.
PubMed 11067378Tornatore JB, Hill E, Laboff JA, McGann ME. Self-administered screening for mild cognitive impairment: initial validation of a computerized test battery. J Neuropsychiatry Clin Neurosci. 2005 Winter;17(1):98-105. doi: 10.1176/jnp.17.1.98.
PubMed 15746489Walsh SP, Raman R, Jones KB, Aisen PS; Alzheimer's Disease Cooperative Study Group. ADCS Prevention Instrument Project: the Mail-In Cognitive Function Screening Instrument (MCFSI). Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S170-8. doi: 10.1097/01.wad.0000213879.55547.57.
PubMed 17135810
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old
- ClinicalTrials.gov ID
- NCT00546767
- Acronym / sponsor ID
- HBA / IA0123
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Oct 2007 (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.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mail and Live Phone | Experimental | Behavioral: Mail and Live Phone |
| IVR | Experimental | Behavioral: Interactive Voice Response (IVR) |
| Computer Kiosk | Experimental | Behavioral: Home-based Computer Kiosk |
| Traditional | Active comparator | Behavioral: Traditional Evaluation Instruments |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age 75 and older
- Willing to sign consent
- Willing to take multi-vitamins provided by the study
- Minimal computer skills or willingness to learn (as demonstrated by completion during screening of a demonstration module for each arm)
- English fluency
Key exclusion criteria (8 listed)
- Dementia
- Use of prescription cognitive-enhancing drugs at entry (e.g. Aricept, Razadyne, Exelon, Namenda)
- Intent to continue use of own multi-vitamins (for the duration of the study participants must agree to take only study-distributed multi-vitamins)
- History or presence of major psychiatric, neurological or neurodegenerative conditions associated with significant cognitive impairment such as major stroke, Parkinson's disease, Multiple Sclerosis or Huntington's disease. Transient Ischemic Attack (TIA) is acceptable if over 6 months ago
- Medical conditions associated with life expectancy of less than 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mail and Live PhoneThis group will receive assessments of all domains by mail, except for the cognitive performance assessment which will be administered via phone by a live, trained evaluator. Medication compliance will be monitored by a written medication log which will be returned by mail with the other mail-in assessments. | Behavioural | Mail and Live Phone |
| Interactive Voice Response (IVR)In this group, participants will be asked to answer questions via an automated phone system using interactive voice recognition (IVR) and key-pad response entry. Medication compliance will be monitored by the same method. A standard large-key telephone and training in the use of the interactive phone system will be provided to all participants. | Behavioural | IVR |
| Home-based Computer KioskParticipants at entry will receive a special Kiosk-like device for collecting assessment information and will be taught to use this device. The user interface will consist of a monitor with a touch screen and a telephone handset, similar to what is often used in museum displays. Pre-recorded instructions will be delivered through the handset as well as displayed visually on the screen. Data will be collected using the handset's high-quality microphone. Daily activity assessments of timed medication use will be obtained via an automated medication tracking device. | Behavioural | Computer Kiosk |
| Traditional Evaluation InstrumentsEvaluation methods typically used in clinical trials | Behavioural | Traditional |
Primary outcome
Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained
Time frame: 4 years
Efficiency Data -- staff time required to successfully complete data collection
Time frame: Each experimental visit
Transition from cognitive health to impairment
Time frame: 4 years
Method-Specific Adherence, including medication adherence
Time frame: 4 years
Rate of change in domains of assessment
Time frame: 4 years
2 secondary outcomes
Research blood samples
Time frame: 4 years
Safety Assessments: symptom checklist and adverse event checklist
Time frame: 4 years
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 16 Sep 2014.
- Background: PubMed 17135809Galasko D, Bennett DA, Sano M, Marson D, Kaye J, Edland SD; Alzheimer's Disease Cooperative Study. ADCS Prevention Instrument Project: assessment of instrumental activities of daily living for community-dwelling elderly individuals in dementia prevention clinical trials. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S152-69. doi: 10.1097/01.wad.0000213873.25053.2b.
- Background: PubMed 11700161Mundt JC, Ferber KL, Rizzo M, Greist JH. Computer-automated dementia screening using a touch-tone telephone. Arch Intern Med. 2001 Nov 12;161(20):2481-7. doi: 10.1001/archinte.161.20.2481.
- Background: PubMed 11067378Piette JD. Interactive voice response systems in the diagnosis and management of chronic disease. Am J Manag Care. 2000 Jul;6(7):817-27.
- Background: PubMed 15746489Tornatore JB, Hill E, Laboff JA, McGann ME. Self-administered screening for mild cognitive impairment: initial validation of a computerized test battery. J Neuropsychiatry Clin Neurosci. 2005 Winter;17(1):98-105. doi: 10.1176/jnp.17.1.98.
- Background: PubMed 17135810Walsh SP, Raman R, Jones KB, Aisen PS; Alzheimer's Disease Cooperative Study Group. ADCS Prevention Instrument Project: the Mail-In Cognitive Function Screening Instrument (MCFSI). Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S170-8. doi: 10.1097/01.wad.0000213879.55547.57.
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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.
Mary Sano, PhD principal investigator
Mount Sinai Medical School
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mail and Live Phone, Interactive Voice Response (IVR) and Home-based Computer Kiosk in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 28 sites 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 11 inclusion and 8 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 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites 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?
Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained (time frame: 4 years). The study lists 5 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 NCT00546767, which also lists 5 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 16 Sep 2014.