Mild Cognitive Impairment Clinical Trial
— REINVENTOfficial title:
REINVENT:A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
Verified date | May 2016 |
Source | Quintiles, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. - 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 |
Observational Model: Case-Crossover, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc | Gilbert | Arizona |
Lead Sponsor | Collaborator |
---|---|
Quintiles, Inc. | Biogen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mini Mental State Examination | 30 days, 90 days | No | |
Primary | Change in Clinical Dementia Rating Sum of Boxes | 30 days, 90 days | No | |
Primary | Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale | 30 days, 90 days | No | |
Primary | Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) | 30 days, 90 days | No |
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