DementiaCOMET-ADNCT01362686
Comparative Research of Alzheimer's Disease Drugs
A study testing Donepezil, Galantamine and Rivastigmine in people with Dementia and Alzheimer's Disease, run by Indiana University at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Alzheimer's Disease
- What is being tested?
- Donepezil, Galantamine and Rivastigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- prior serious adverse event from the study medications
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Touchpoint
Fishers, Indiana, 46037
Methodist Center for Geriatric Medicine
Indianapolis, Indiana, 46202
University Clinical Neurology
Indianapolis, Indiana, 46202
Wishard Health Services
Indianapolis, Indiana, 46202
St. Vincent Center for Healthy Aging
Indianapolis, Indiana, 46260
About this study
Official title: Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs
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.
Read the 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:
- provide de-identified access to the INPC database for CER work
- capture, store, and track a broader array of health care outcomes important to patients and their caregivers (e.g. behavioral symptoms due to dementia);
- 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.
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- Donepezil, Galantamine, Rivastigmine
- Keywords
- diagnosis of Alzheimer's disease, medication adherence
- Medical subject headings
- Dementia, Alzheimer Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Aricept
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.
GalantamineDrug
Also called Razadyne
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.
RivastigmineDrug
Also called Exelon
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.
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Experimental | See intervention note. Receives: Drug: Donepezil |
| Galantamine | Experimental | See intervention note. Receives: Drug: Galantamine |
| Rivastigmine | Experimental | See intervention note. Receives: Drug: Rivastigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuation 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.
Measured: 6, 12, and 18 week interviews from enrollment
Secondary outcomes (2)
Neuropsychiatric Inventory (NPI)
The NPI is based on a structured interview administered to an informal caregiver and has been adopted by the Alzheimer's Disease Cooperative Studies 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.9 For each of 12 symptoms, if the caregiver reports the presence of psychopathology, a frequency and severity score are multiplied to yield a possible item score range of 0-12, and a possible total score range of 0-144. The NPI can be used to assess changes in the patient's behavior over the past month. The NPI also assesses the level of caregiver distress attributable to each of the 12 patient behaviors, with a possible total caregiver distress score range of 0-60. Higher scores indicate higher severity of psychopathology and caregiver disress. The NPI has excellent reliability and validity.
Measured: Baseline, 6, 12, 18 week interviews from enrollment
Healthy Aging Brain Care (HABC)-Monitor
The current HABC-Monitor includes 30 items covering four clinically relevant domains of dementia, ie, cognitive, functional, behavioral, and psychological symptoms, and caregiver quality of life. For brevity and practical use in the clinical setting, each item on the four scales was designed to have the same item response options consisting of four categories that use the frequency of the target problem in the past 2 weeks. The HABC- Monitor took approximately 6 minutes to complete. The scores of the four scales are summed to create the total scores which were used in this analysis.The higher the total score, the higher the level of self reported caregiver burden. The minimum score is 0 and the maximum score is 90.
Measured: baseline, 6, 12, and 18 week interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Low study accrual caused the study to be ended early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.
- Investigators
- Malaz Boustani, MD, MPH, Principal investigator, Regenstrief Institute, Center for Aging Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362686
- Sponsor's protocol ID
- R01HS019818-01
- Other IDs
- R01HS019818-01
- Acronym
- COMET-AD
- Status last verified
- Jan 2017
- First submitted
- 26 May 2011
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 16684985Boustani 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.
PubMed 16050849Boustani 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.
PubMed 23204843Campbell 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.
PubMed 19554093Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
PubMed 39498781Campbell 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.
PubMed 28295141Campbell 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.
PubMed 23782591
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs
- ClinicalTrials.gov ID
- NCT01362686
- Acronym / sponsor ID
- COMET-AD / R01HS019818-01
- Conditions
- Dementia, Alzheimer's Disease
- Keywords
- diagnosis of Alzheimer's disease, medication adherence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low study accrual caused the study to be ended early.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Posted 27 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- provide de-identified access to the INPC database for CER work
- capture, store, and track a broader array of health care outcomes important to patients and their caregivers (e.g. behavioral symptoms due to dementia);
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Donepezil | Experimental | Drug: DonepezilSee intervention note. |
| Galantamine | Experimental | Drug: GalantamineSee intervention note. |
| Rivastigmine | Experimental | Drug: RivastigmineSee intervention note. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- prior serious adverse event from the study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilAlso: AriceptThe 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. | Drug | Donepezil |
| GalantamineAlso: RazadyneThe 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. | Drug | Galantamine |
| RivastigmineAlso: ExelonThe 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. | Drug | Rivastigmine |
Primary outcome
Discontinuation Rates
Time frame: 6, 12, and 18 week interviews from enrollment
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.
2 secondary outcomes
Neuropsychiatric Inventory (NPI)
Time frame: Baseline, 6, 12, 18 week interviews from enrollment
Healthy Aging Brain Care (HABC)-Monitor
Time frame: baseline, 6, 12, and 18 week interviews
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16684985Callahan 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.
- Background: PubMed 16050849Boustani 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.
- Background: PubMed 23204843Boustani 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.
- Background: PubMed 19554093Campbell 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.
- Derived from this study: PubMed 39498781Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
- Derived from this study: PubMed 28295141Campbell 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.
- Derived from this study: PubMed 23782591Campbell 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.
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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.
Malaz Boustani, MD, MPH principal investigator
Regenstrief Institute, Center for Aging Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donepezil, Galantamine and Rivastigmine in people with Dementia and Alzheimer's Disease, run by Indiana University at 5 sites 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 1 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: stopped early, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 27 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Discontinuation Rates (time frame: 6, 12, and 18 week interviews from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01362686, which also lists 7 linked publications.
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 Feb 2017.