Clinical trial NCT01362686: Comparative Research of Alzheimer's Disease Drugs
Official title: Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dementia
Alzheimer's Disease
Keywords: diagnosis of Alzheimer's disease
medication adherence
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2011-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conduct a comparative effectiveness clinical trial of medication treatment for behavioral symptoms of Alzheimer's disease in a group of real-world memory care clinics with enhanced access to the Indiana Network for Patient Care.

Detailed description: The overarching goal of this proposal is to enhance the existing information technology infrastructure in Central Indiana to improve the nation's capacity to conduct comparative effectiveness research (CER). Consistent with the instructions in RFA-HS-10-005, the investigators propose to apply these new capacities to a novel CER project evaluating treatment for Alzheimer's disease. Alzheimer's disease has been identified as a first quartile CER priority. This proposal represents collaboration between the Medical Informatics Program at the Regenstrief Institute, Inc (a world leader in health information technology) and two Indiana University research programs: the Center for Aging Research and the Division of Clinical Pharmacology. These programs have an established track record in research relevant to under-served populations. Thus, this proposal combines considerable investigator, environment, and research strengths to continue to build a novel CER infrastructure in support of the nation's evidentiary CER priorities.

Throughout this proposal, the investigators use the AHRQ definition of CER: the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings." The investigators also refer to a clinical trial of medication treatment for behavioral symptoms of Alzheimer's disease as the specific CER proposed to demonstrate the potential of our new infrastructure. However, the investigators stress that the enhancements proposed to existing infrastructure would support a broad portfolio of CER across an array of priority conditions. The investigators are also proposing enhancements in our privacy and confidentiality technology that would allow researchers from across the country to access de-identified data in support of CER. In summary, the investigators are proposing to add new CER knowledge on Alzheimer' disease and thereby field test new information technology capacities important to a wide range of CER projects while also increasing our capacity to provide data and opportunities for nationwide CER.

The derivation of meaningful and actionable evidence from CER ultimately depends on capturing relevant, comprehensive and accurate data about treatment decisions, patients' clinical status, their care processes and environment, and the health outcomes they experience and value. Such data must be tracked longitudinally in order to determine temporal relationships, cause-effect paradigms, and the efficacy of specific clinical interventions in the context of other conditions, interventions, and goals of care. At Indiana University and the Regenstrief Institute, the investigators have four decades of experience and a well-documented, world-class clinical informatics and research infrastructure for capturing, storing, querying and analyzing treatment patterns and patients' clinical outcomes.

The maturation of this health information technology is now embodied within the Indiana Network for Patient Care (INPC), a fully-operational regional health information exchange. The investigators are well positioned to expand and leverage this infrastructure in support of local and national multi-site clinical trials in comparative effectiveness. The specific aims of this proposal are to:

1.0 PROSPECT STUDY: Enhance our existing information technology infrastructure to:

1. provide de-identified access to the INPC database for CER work
2. capture, store, and track a broader array of health care outcomes important to patients and their caregivers (e.g. behavioral symptoms due to dementia);
3. support providers' and caregivers' and researchers' increasing need to work in teams by providing new tools for communication and co-management (e.g. collaborative care and research)

2.0 COMET-AD STUDY: Conduct comparative effectiveness clinical trial of medication treatment for behavioral symptoms of Alzheimer's disease in a group of real-world memory care clinics with enhanced access to the Indiana Network for Patient Care.

Eligibility criteria: Inclusion Criteria:

* older adults with a diagnosis of possible or probable Alzheimer's disease
* planning to initiate treatment with a cholinesterase inhibitor
* planning to continue care in the memory care practice
* participation by a family caregiver willing to complete the study outcome assessments
* access to a telephone
* ability to understand English-Language survey instruments

Exclusion Criteria:

• prior serious adverse event from the study medications

Primary outcomes:
measure: Discontinuation Rates
timeFrame: 6, 12, and 18 week interviews from enrollment
Secondary outcomes:
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Baseline, 6, 12, 18 week interviews from enrollment
measure: Healthy Aging Brain Care (HABC)-Monitor
timeFrame: baseline, 6, 12, and 18 week interviews
Other outcomes:
Locations:
city: Fishers
country: United States
facility: Touchpoint
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Center for Geriatric Medicine
state: Indiana
city: Indianapolis
country: United States
facility: University Clinical Neurology
state: Indiana
city: Indianapolis
country: United States
facility: Wishard Health Services
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Center for Healthy Aging
state: Indiana
Study officials:
affiliation: Regenstrief Institute, Center for Aging Research
name: Malaz Boustani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57. doi: 10.1001/jama.295.18.2148.
citation: Boustani M, Callahan CM, Unverzagt FW, Austrom MG, Perkins AJ, Fultz BA, Hui SL, Hendrie HC. Implementing a screening and diagnosis program for dementia in primary care. J Gen Intern Med. 2005 Jul;20(7):572-7. doi: 10.1111/j.1525-1497.2005.0126.x.
citation: Boustani MA, Frame A, Munger S, Healey P, Westlund J, Farlow M, Hake A, Austrom MG, Shepard P, Bubp C, Azar J, Nazir A, Adams N, Campbell NL, Chehresa A, Dexter P. Connecting research discovery with care delivery in dementia: the development of the Indianapolis Discovery Network for Dementia. Clin Interv Aging. 2012;7:509-16. doi: 10.2147/CIA.S36078. Epub 2012 Nov 16.
citation: Campbell N, Boustani M, Limbil T, Ott C, Fox C, Maidment I, Schubert CC, Munger S, Fick D, Miller D, Gulati R. The cognitive impact of anticholinergics: a clinical review. Clin Interv Aging. 2009;4:225-33. doi: 10.2147/cia.s5358. Epub 2009 Jun 9.
citation: Campbell NL, Perkins AJ, Gao S, Skaar TC, Li L, Hendrie HC, Fowler N, Callahan CM, Boustani MA. Adherence and Tolerability of Alzheimer's Disease Medications: A Pragmatic Randomized Trial. J Am Geriatr Soc. 2017 Jul;65(7):1497-1504. doi: 10.1111/jgs.14827. Epub 2017 Mar 14.
citation: Campbell NL, Dexter P, Perkins AJ, Gao S, Li L, Skaar TC, Frame A, Hendrie HC, Callahan CM, Boustani MA. Medication adherence and tolerability of Alzheimer's disease medications: study protocol for a randomized controlled trial. Trials. 2013 May 4;14:125. doi: 10.1186/1745-6215-14-125.