Comparative Research of Alzheimer's Disease Drugs

Dementia Clinical Trial

— COMET-AD  

Official title:

Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01362686
• Other study ID #: R01HS019818-01
• Secondary ID: R01HS019818-01
• Status: Terminated
• Phase: N/A
• First received: May 26, 2011
• Last updated: April 11, 2016
• Start date: April 2011
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• Donepezil
The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.
• Galantamine
The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.
• Rivastigmine
The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.

Locations

Country	Name	City	State
United States	Touchpoint	Fishers	Indiana
United States	Methodist Center for Geriatric Medicine	Indianapolis	Indiana
United States	St. Vincent Center for Healthy Aging	Indianapolis	Indiana
United States	University Clinical Neurology	Indianapolis	Indiana
United States	Wishard Health Services	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Boustani M, Healey P, Sennour Y, Munger S. Indianapolis Discovery Network for Dementia. JAGS 2007; 55:S44

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. — View 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. Epub 2009 Jun 9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuation and Adherence Rates	We are not seeking to establish efficacy of these three medications for the indication of Alzheimer's disease. Each of these medications already has FDA-approval for Alzheimer's. The primary outcome measure is the discontinuation rate among the three medications. Based on previous systematic reviews, these rates are reportedly in the range of 30% by 12 weeks compared with placebo. We will determine the approximate date of discontinuation by self-reports from the caregiver through the telephone-based interview at 6, 12, and 18 weeks.	6, 12, and 18 week interviews from enrollment	No
Secondary	Neuropsychiatric Inventory (NPI)	The NPI has been adopted by the Alzheimer's Disease Cooperative Studies (ADCS) Group to obtain information on the presence of psychopathology in behavioral areas including delusions, apathy, hallucinations, disinhibition, agitation, depression, aberrant motor behavior, anxiety, night-time behavior, and euphoria. There are also follow-up questions to assess frequency, severity, and the level of caregiver distress due to the behavior. The administration time is about 20 minutes and will be administered to the caregiver by telephone.	6, 12, 18 week interviews from enrollment	No
Secondary	HABC Monitor	Its face validity was assessed based on feedback of an interdisciplinary team of 22 dementia care specialists. The panel selected 15 items captured from the AD8, the PHQ-9, and the NPI-Q to measure cognitive, behavioral and psychological symptoms of dementia. However, the panel also determined it necessary to develop 17 additional items to capture the functional, safety and caregiver burden aspects of dementia care. The HABC Monitor takes about 5 minutes to complete. The current HABC Monitor has two versions, a caregiver version and a self-report version.	baseline, 6, 12, and 18 week interviews	No