Mild Cognitive ImpairmentREINVENTNCT02778438
A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Quintiles, Inc. at 1 site in United States.
Trial summary
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated through a single main study site. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Aug 2016
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 subjects with mild cognitive impairment due to AD, based on core clinical diagnostic criteria from the National Institute on Aging and Alzheimer's Association workgroup [Albert 2011]
Who may be able to join
- Age at screening 50 to 85 years, inclusive, at the time of informed consent.
- Diagnosis of mild cognitive deficits due to AD based on the core clinical diagnostic criteria of the National Institute of Aging and Alzheimer's Association (Albert 2011; McKhann 2011) and reviewed centrally by a main study site Principal Investigator
- Mini Mental State Examination (MMSE) score of 24-27, inclusive at screening
- Subject (or legally authorized representative) is willing and able to provide written informed consent
- Existence of a reliable study partner (i.e., someone who spends at least 2 days a week with the subject) or caregiver who is willing to attend study visits with the subject
- Willing and able to travel to the main study site (via provided transportation) for either Visit 2 or Visit 3
Who cannot join
- Any medical or neurological condition (other than AD) that might be a contributing cause of the subject's cognitive impairment
- Have had a stroke or transient ischemic attack (TIA) or unexplained loss of consciousness in the past 1 year
- Clinically significant psychiatric illness in past 6 months
- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- Alcohol or substance abuse in past 1 year
- History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class III or IV), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to Screening.
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- Uncontrolled hypertension defined as a systolic blood pressure [SBP]/diastolic blood pressure [DBP] readings > 165/100 mmHg at Screening, or persistent SBP/DBP readings prior to enrollment that in the opinion of the Investigator are indicative of chronic uncontrolled hypertension.
- Any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, or impair the subject's ability to perform cognitive testing.
- Use of allowed chronic medications at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 or use of AD medications (including but not limited to donepezil, rivastigmine, galantamine, tacrine, and memantine) at doses that have not been stable for at least 8 weeks prior to Screening Visit 1.
- Participation in any interventional clinical research study within 30 days prior to screening, or during study conduct
- In the opinion of the Investigator, presence of any other clinical conditions (e.g., life expectancy, co-existing disease) or other characteristics that would likely interfere with completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc
Gilbert, Arizona, 85234
About this study
Official title: REINVENT:A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit.
Read the detailed description
Mobile platforms have been leveraged in a variety of industries to drive dramatic efficiency gains. The technology enables redesign of key processes allowing for the more efficient use of labor and capital leading to better performance outcomes. Telehealth is the use of electronic information and mobile telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration. Much of the focus for the Institute of Medicine and other government agencies has been the application of telehealth to improve access to healthcare and specialized expertise by extending the reach of scarce resources to underserved populations. These platforms are also routinely deployed as disease management tools. A natural extension of these aims is the use of telehealth in the clinical development process, where both improved efficiency and the ability to be more inclusive of a broader patient population are critical steps in modernizing the clinical trial.
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from between 9 and 11 qualified Radiant Clinical Research primary care physicians (PCP), coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit. A 60-day interval is required between Visits 2 and 3 to reduce learning effects commonly observed with repeated administration of cognitive assessments.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini Mental State Examination
Measured: 30 days, 90 days
Change in Clinical Dementia Rating Sum of Boxes
Measured: 30 days, 90 days
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale
Measured: 30 days, 90 days
Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)
Measured: 30 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quintiles, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Jeffrey Shy, MD, Principal investigator, Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778438
- Sponsor's protocol ID
- REI-001
- Acronym
- REINVENT
- Status last verified
- May 2016
- First submitted
- 27 Apr 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REINVENT:A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
- ClinicalTrials.gov ID
- NCT02778438
- Acronym / sponsor ID
- REINVENT / REI-001
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Quintiles, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 May 2016 (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.
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit.
Detailed description
Mobile platforms have been leveraged in a variety of industries to drive dramatic efficiency gains. The technology enables redesign of key processes allowing for the more efficient use of labor and capital leading to better performance outcomes. Telehealth is the use of electronic information and mobile telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration. Much of the focus for the Institute of Medicine and other government agencies has been the application of telehealth to improve access to healthcare and specialized expertise by extending the reach of scarce resources to underserved populations. These platforms are also routinely deployed as disease management tools. A natural extension of these aims is the use of telehealth in the clinical development process, where both improved efficiency and the ability to be more inclusive of a broader patient population are critical steps in modernizing the clinical trial.
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from between 9 and 11 qualified Radiant Clinical Research primary care physicians (PCP), coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit. A 60-day interval is required between Visits 2 and 3 to reduce learning effects commonly observed with repeated administration of cognitive assessments.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 subjects with mild cognitive impairment due to AD, based on core clinical diagnostic criteria from the National Institute on Aging and Alzheimer's Association workgroup [Albert 2011]
Key inclusion criteria (6 listed)
- Age at screening 50 to 85 years, inclusive, at the time of informed consent.
- Diagnosis of mild cognitive deficits due to AD based on the core clinical diagnostic criteria of the National Institute of Aging and Alzheimer's Association (Albert 2011; McKhann 2011) and reviewed centrally by a main study site Principal Investigator
- Mini Mental State Examination (MMSE) score of 24-27, inclusive at screening
- Subject (or legally authorized representative) is willing and able to provide written informed consent
- Existence of a reliable study partner (i.e., someone who spends at least 2 days a week with the subject) or caregiver who is willing to attend study visits with the subject
Key exclusion criteria (11 listed)
- Any medical or neurological condition (other than AD) that might be a contributing cause of the subject's cognitive impairment
- Have had a stroke or transient ischemic attack (TIA) or unexplained loss of consciousness in the past 1 year
- Clinically significant psychiatric illness in past 6 months
- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- Alcohol or substance abuse in past 1 year
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
Change in Mini Mental State Examination
Time frame: 30 days, 90 days
Change in Clinical Dementia Rating Sum of Boxes
Time frame: 30 days, 90 days
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale
Time frame: 30 days, 90 days
Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)
Time frame: 30 days, 90 days
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 27 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Jeffrey Shy, MD principal investigator
Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc
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 Mild Cognitive Impairment and Alzheimer's Disease, run by Quintiles, Inc. 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 6 inclusion and 11 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 27 Sep 2016. 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?
Change in Mini Mental State Examination (time frame: 30 days, 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2016.