Alzheimer DiseaseREVEALNCT00462917
REVEAL III: Risk Evaluation and Education for Alzheimer's Disease
A study testing Pleiotropic info, in-person disclosure, AD-only info, in-person disclosure and Pleiotropic info, phone disclosure in people with Alzheimer Disease, run by Brigham and Women's Hospital at 4 sites in United States.
Trial summary
The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Pleiotropic info, in-person disclosure, AD-only info, in-person disclosure and Pleiotropic info, phone disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2007to Oct 2009
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years to 85 years old
Who cannot join
- Unable to visit a study site
- Current untreated depression or anxiety
- Family history of AD diagnosed under age 60
- More than one first-degree relative diagnosed with AD (e.g. Mother and brother)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Boston University School of Medicine
Boston, Massachusetts, 02118
Case Western Reserve University
Cleveland, Ohio, 44120
Howard University
Washington D.C., District of Columbia, 20059
About this study
Official title: Risk Evaluation and Education for Alzheimer's Disease
The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.
Read the detailed description
Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene that has been identified which can provide information about a person's chances of developing Alzheimer's diseases. Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimer's disease (AD). The REVEAL I Study, funded in 1999, showed that an Alzheimer's disease genetic risk assessment can be given to relatives of people with AD in a safe way. REVEAL II, which was funded in 2003, demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm. REVEAL III will further study different ways of providing genetic risk information for Alzheimer's disease.
Participation in this study will entail an initial screening phone call to determine eligibility, followed by a phone interview which will ask about demographic information and thoughts and feelings about AD. Participants will complete a mailed survey. Following completion of the survey, a genetic counselor will meet with the participant at the clinic to review family and medical history, administer additional questionnaires asking about AD and genetic testing, and draw blood for genetic testing. Results will be disclosed either in person or over the phone about 3 to 4 weeks later. The genetic counselor will make a brief follow-up phone call 1 week after that. The participant will visit the clinic twice to provide additional information, at 6 weeks and 6 months after disclosure. Finally, the participant will complete a mailed 12 month survey, and the genetic counselor will make a brief follow-up phone call.
- Conditions
- Alzheimer Disease
- Being tested
- Pleiotropic info, in-person disclosure, AD-only info, in-person disclosure, Pleiotropic info, phone disclosure, AD-only info, phone disclosure
- Keywords
- disease /disorder proneness /risk, family genetics, genetic counseling, genetic marker, genetic polymorphism, genetic screening, genetic susceptibility
- Medical subject headings
- Alzheimer Disease, Disease Susceptibility, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleiotropic info, in-person disclosureBehavioural
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session.
AD-only info, in-person disclosureBehavioural
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
Pleiotropic info, phone disclosureBehavioural
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session.
AD-only info, phone disclosureBehavioural
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
| Study group | Role | What they receive |
|---|---|---|
| Pleiotropic info, in-person disclosure | Experimental | Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment Receives: Behavioral: Pleiotropic info, in-person disclosure |
| AD-only info, phone disclosure | Experimental | Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment Receives: Behavioral: AD-only info, phone disclosure |
| Pleiotropic info, phone disclosure | Experimental | Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment Receives: Behavioral: Pleiotropic info, phone disclosure |
| AD-only info, in-person disclosure | Active comparator | Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment Receives: Behavioral: AD-only info, in-person disclosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiological Studies-Depression Scale (CES-D)
A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Measured: 6 weeks, 6 months, and 12 months post-disclosure
Beck Anxiety Inventory (BAI)
A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
Measured: 6 weeks, 6 months, 12 months post-disclosure
Secondary outcomes (1)
Impact of Events Scale (IES)
A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.
Measured: 6 weeks, 6 months, 12 months post-disclosure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2009
- Study completionOct 2009
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 (10)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Principal investigator, Robert C. Green, MD, MPH, Brigham and Women's Hospital
- Investigators
- Robert Green, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462917
- Sponsor's protocol ID
- IA0113
- Other IDs
- R01HG002213
- Acronym
- REVEAL
- Status last verified
- Sep 2018
- First submitted
- 17 Apr 2007
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hipps YG, Roberts JS, Farrer LA, Green RC. Differences between African Americans and Whites in their attitudes toward genetic testing for Alzheimer's disease. Genet Test. 2003 Spring;7(1):39-44. doi: 10.1089/109065703321560921.
PubMed 12820701Roberts JS, LaRusse SA, Katzen H, Whitehouse PJ, Barber M, Post SG, Relkin N, Quaid K, Pietrzak RH, Cupples LA, Farrer LA, Brown T, Green RC. Reasons for seeking genetic susceptibility testing among first-degree relatives of people with Alzheimer disease. Alzheimer Dis Assoc Disord. 2003 Apr-Jun;17(2):86-93. doi: 10.1097/00002093-200304000-00006.
PubMed 12794385Roberts JS, Barber M, Brown TM, Cupples LA, Farrer LA, LaRusse SA, Post SG, Quaid KA, Ravdin LD, Relkin NR, Sadovnick AD, Whitehouse PJ, Woodard JL, Green RC. Who seeks genetic susceptibility testing for Alzheimer's disease? Findings from a multisite, randomized clinical trial. Genet Med. 2004 Jul-Aug;6(4):197-203. doi: 10.1097/01.gim.0000132688.55591.77.
PubMed 15266207LaRusse S, Roberts JS, Marteau TM, Katzen H, Linnenbringer EL, Barber M, Whitehouse P, Quaid K, Brown T, Green RC, Relkin NR. Genetic susceptibility testing versus family history-based risk assessment: Impact on perceived risk of Alzheimer disease. Genet Med. 2005 Jan;7(1):48-53. doi: 10.1097/01.gim.0000151157.13716.6c.
PubMed 15654228Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Green RC; REVEAL (Risk Evaluation and Education for Alzheimer's Disease) Study Group. Genetic risk assessment for adult children of people with Alzheimer's disease: the Risk Evaluation and Education for Alzheimer's Disease (REVEAL) study. J Geriatr Psychiatry Neurol. 2005 Dec;18(4):250-5. doi: 10.1177/0891988705281883.
PubMed 16306249Roberts JS, Christensen KD, Green RC. Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. Clin Genet. 2011 Nov;80(5):407-14. doi: 10.1111/j.1399-0004.2011.01739.x. Epub 2011 Jul 18.
PubMed 21696382Christensen KD, Uhlmann WR, Roberts JS, Linnenbringer E, Whitehouse PJ, Royal CDM, Obisesan TO, Cupples LA, Butson MB, Fasaye GA, Hiraki S, Chen CA, Siebert U, Cook-Deegan R, Green RC. A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone. Genet Med. 2018 Jan;20(1):132-141. doi: 10.1038/gim.2017.103. Epub 2017 Jul 20.
PubMed 28726810Christensen KD, Roberts JS, Whitehouse PJ, Royal CD, Obisesan TO, Cupples LA, Vernarelli JA, Bhatt DL, Linnenbringer E, Butson MB, Fasaye GA, Uhlmann WR, Hiraki S, Wang N, Cook-Deegan R, Green RC; REVEAL Study Group*. Disclosing Pleiotropic Effects During Genetic Risk Assessment for Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2016 Feb 2;164(3):155-63. doi: 10.7326/M15-0187. Epub 2016 Jan 26.
PubMed 26810768Christensen KD, Roberts JS, Zikmund-Fisher BJ, Kardia SL, McBride CM, Linnenbringer E, Green RC; REVEAL Study Group. Associations between self-referral and health behavior responses to genetic risk information. Genome Med. 2015 Jan 31;7(1):10. doi: 10.1186/s13073-014-0124-0. eCollection 2015.
PubMed 25642295Besser AG, Sanderson SC, Roberts JS, Chen CA, Christensen KD, Lautenbach DM, Cupples LA, Green RC. Factors affecting recall of different types of personal genetic information about Alzheimer's disease risk: the REVEAL study. Public Health Genomics. 2015;18(2):78-86. doi: 10.1159/000368888. Epub 2015 Jan 24.
PubMed 25634646
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Evaluation and Education for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00462917
- Acronym / sponsor ID
- REVEAL / IA0113
- Conditions
- Alzheimer Disease
- Keywords
- disease /disorder proneness /risk, family genetics, genetic counseling, genetic marker, genetic polymorphism, genetic screening, genetic susceptibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- Mar 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.
Detailed description
Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene that has been identified which can provide information about a person's chances of developing Alzheimer's diseases. Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimer's disease (AD). The REVEAL I Study, funded in 1999, showed that an Alzheimer's disease genetic risk assessment can be given to relatives of people with AD in a safe way. REVEAL II, which was funded in 2003, demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm. REVEAL III will further study different ways of providing genetic risk information for Alzheimer's disease.
Participation in this study will entail an initial screening phone call to determine eligibility, followed by a phone interview which will ask about demographic information and thoughts and feelings about AD. Participants will complete a mailed survey. Following completion of the survey, a genetic counselor will meet with the participant at the clinic to review family and medical history, administer additional questionnaires asking about AD and genetic testing, and draw blood for genetic testing. Results will be disclosed either in person or over the phone about 3 to 4 weeks later. The genetic counselor will make a brief follow-up phone call 1 week after that. The participant will visit the clinic twice to provide additional information, at 6 weeks and 6 months after disclosure. Finally, the participant will complete a mailed 12 month survey, and the genetic counselor will make a brief follow-up phone call.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pleiotropic info, in-person disclosure | Experimental | Behavioral: Pleiotropic info, in-person disclosureIncidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment |
| AD-only info, phone disclosure | Experimental | Behavioral: AD-only info, phone disclosureAlzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment |
| Pleiotropic info, phone disclosure | Experimental | Behavioral: Pleiotropic info, phone disclosureIncidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment |
| AD-only info, in-person disclosure | Active comparator | Behavioral: AD-only info, in-person disclosureAlzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 years to 85 years old
Key exclusion criteria (4 listed)
- Unable to visit a study site
- Current untreated depression or anxiety
- Family history of AD diagnosed under age 60
- More than one first-degree relative diagnosed with AD (e.g. Mother and brother)
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 |
|---|---|---|
| Pleiotropic info, in-person disclosureIndividuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information. Genetic counselors communicate results to participants during an in-person disclosure session. | Behavioural | Pleiotropic info, in-person disclosure |
| AD-only info, in-person disclosureIndividuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping. Genetic counselors communicate results to participants during an in-person disclosure session. | Behavioural | AD-only info, in-person disclosure |
| Pleiotropic info, phone disclosureIndividuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information. Genetic counselors communicate results to participants during a telephone disclosure session. | Behavioural | Pleiotropic info, phone disclosure |
| AD-only info, phone disclosureIndividuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping. Genetic counselors communicate results to participants during an in-person disclosure session. | Behavioural | AD-only info, phone disclosure |
Primary outcome
Center for Epidemiological Studies-Depression Scale (CES-D)
Time frame: 6 weeks, 6 months, and 12 months post-disclosure
A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Beck Anxiety Inventory (BAI)
Time frame: 6 weeks, 6 months, 12 months post-disclosure
A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
1 secondary outcome
Impact of Events Scale (IES)
Time frame: 6 weeks, 6 months, 12 months post-disclosure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12820701Hipps YG, Roberts JS, Farrer LA, Green RC. Differences between African Americans and Whites in their attitudes toward genetic testing for Alzheimer's disease. Genet Test. 2003 Spring;7(1):39-44. doi: 10.1089/109065703321560921.
- Background: PubMed 12794385Roberts JS, LaRusse SA, Katzen H, Whitehouse PJ, Barber M, Post SG, Relkin N, Quaid K, Pietrzak RH, Cupples LA, Farrer LA, Brown T, Green RC. Reasons for seeking genetic susceptibility testing among first-degree relatives of people with Alzheimer disease. Alzheimer Dis Assoc Disord. 2003 Apr-Jun;17(2):86-93. doi: 10.1097/00002093-200304000-00006.
- Background: PubMed 15266207Roberts JS, Barber M, Brown TM, Cupples LA, Farrer LA, LaRusse SA, Post SG, Quaid KA, Ravdin LD, Relkin NR, Sadovnick AD, Whitehouse PJ, Woodard JL, Green RC. Who seeks genetic susceptibility testing for Alzheimer's disease? Findings from a multisite, randomized clinical trial. Genet Med. 2004 Jul-Aug;6(4):197-203. doi: 10.1097/01.gim.0000132688.55591.77.
- Background: PubMed 15654228LaRusse S, Roberts JS, Marteau TM, Katzen H, Linnenbringer EL, Barber M, Whitehouse P, Quaid K, Brown T, Green RC, Relkin NR. Genetic susceptibility testing versus family history-based risk assessment: Impact on perceived risk of Alzheimer disease. Genet Med. 2005 Jan;7(1):48-53. doi: 10.1097/01.gim.0000151157.13716.6c.
- Background: PubMed 16306249Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Green RC; REVEAL (Risk Evaluation and Education for Alzheimer's Disease) Study Group. Genetic risk assessment for adult children of people with Alzheimer's disease: the Risk Evaluation and Education for Alzheimer's Disease (REVEAL) study. J Geriatr Psychiatry Neurol. 2005 Dec;18(4):250-5. doi: 10.1177/0891988705281883.
- Background: PubMed 21696382Roberts JS, Christensen KD, Green RC. Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. Clin Genet. 2011 Nov;80(5):407-14. doi: 10.1111/j.1399-0004.2011.01739.x. Epub 2011 Jul 18.
- Results publication: PubMed 28726810Christensen KD, Uhlmann WR, Roberts JS, Linnenbringer E, Whitehouse PJ, Royal CDM, Obisesan TO, Cupples LA, Butson MB, Fasaye GA, Hiraki S, Chen CA, Siebert U, Cook-Deegan R, Green RC. A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone. Genet Med. 2018 Jan;20(1):132-141. doi: 10.1038/gim.2017.103. Epub 2017 Jul 20.
- Results publication: PubMed 26810768Christensen KD, Roberts JS, Whitehouse PJ, Royal CD, Obisesan TO, Cupples LA, Vernarelli JA, Bhatt DL, Linnenbringer E, Butson MB, Fasaye GA, Uhlmann WR, Hiraki S, Wang N, Cook-Deegan R, Green RC; REVEAL Study Group*. Disclosing Pleiotropic Effects During Genetic Risk Assessment for Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2016 Feb 2;164(3):155-63. doi: 10.7326/M15-0187. Epub 2016 Jan 26.
- Results publication: PubMed 25642295Christensen KD, Roberts JS, Zikmund-Fisher BJ, Kardia SL, McBride CM, Linnenbringer E, Green RC; REVEAL Study Group. Associations between self-referral and health behavior responses to genetic risk information. Genome Med. 2015 Jan 31;7(1):10. doi: 10.1186/s13073-014-0124-0. eCollection 2015.
- Results publication: PubMed 25634646Besser AG, Sanderson SC, Roberts JS, Chen CA, Christensen KD, Lautenbach DM, Cupples LA, Green RC. Factors affecting recall of different types of personal genetic information about Alzheimer's disease risk: the REVEAL study. Public Health Genomics. 2015;18(2):78-86. doi: 10.1159/000368888. Epub 2015 Jan 24.
- Primary REVEAL Study web site (http://www.genomes2people.org/reveal/)Link provided by the sponsor.
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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.
Robert Green, MD, MPH principal investigator
Brigham and Women's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleiotropic info, in-person disclosure, AD-only info, in-person disclosure and Pleiotropic info, phone disclosure in people with Alzheimer Disease, run by Brigham and Women's Hospital at 4 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 11 Sep 2014). 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?
Center for Epidemiological Studies-Depression Scale (CES-D) (time frame: 6 weeks, 6 months, and 12 months post-disclosure). The study lists 2 primary outcomes in all. 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 NCT00462917, which also lists 10 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 23 Oct 2018.