A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits

NCT02778438 | Completed

• 1 other identifier: REI-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Outcome Measures

Primary Outcomes (4)

• Change in Mini Mental State Examination

  30 days, 90 days

• Change in Clinical Dementia Rating Sum of Boxes

  30 days, 90 days

• Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale

  30 days, 90 days

• Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)

  30 days, 90 days

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 \[Albert 2011\]

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quintiles, Inc.: lead
• Biogen: collaborator

Study Sites (1)

Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc

Gilbert, Arizona, 85234, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Jeffrey Shy, MD

  Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 19, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)