Alzheimer DiseasePhase 4DATNCT01822951
Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)
A Phase 4 study testing Cerebrolysin and Donepezil in people with Alzheimer Disease, run by Ever Neuro Pharma GmbH at 1 site in Austria.
Trial summary
The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to donepezil in patients with mild to moderate dementia of Alzheimer's Type (DAT). In addition, a traditional approach will be taken based on the evaluation of the separate risk and benefit domains in comparison with… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Cerebrolysin and Donepezil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Start not givento Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥50 years of age
- Diagnosis of probable mild to moderate Alzheimer's disease according to DSM-IV-TR and NINCDS-ADRDA criteria (see section 18.2.1)
- Screening MMSE score between 15 and 24, both inclusive
- Modified Hachinski Ischemic score of ≤4
- Hamilton Depression Scale score ≤10
- Brain computerized tomography (CT) or brain magnetic resonance imaging (MRI) scans within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. If no brain CT or brain MRI is available, a brain MRI shall be performed to exclude other causes of dementia-like syndromes.
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- Sufficient language skills to complete all testing without assistance of a language interpreter
- Ability to perform all sections of the ADAS-cog
- Good general health without additional diseases expected to interfere with the study
- Normal B12, folic acid, VDRL, and TSH or without any clinically significant laboratory abnormalities that would be expected to interfere with the study.
- ECG and chest x-ray (if available) without clinically significant laboratory abnormalities that would be expected to interfere with the study.
- Patient is not of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)
- Responsible caregiver (individual who continuously attends to the needs of the person or dependent adult), who agrees to be present during study conduct.
- Written informed consent obtained from the patient and caregiver (and legally authorized representative or guardian if different from caregiver) prior to entry into the study (Screening Visit)
Who cannot join
- Any abnormalities associated with significant central nervous disease other than Alzheimer's Disease
- Severe psychotic features, confusion, agitation or behavioral problems within the last three months that could lead to difficulties complying with the protocol
- Delusional symptoms are often characteristic of Alzheimer's disease, but patients with symptoms so pronounced that they warrant an alternative psychiatric diagnosis are excluded
- History of alcohol or substance abuse or dependence within the past two years (DSM-IV-TR criteria, see also sections 18.3.1 and 18.3.2)
- History of schizophrenia, schizoaffective disorder, bipolar affective disorder (DSM-IV-TR criteria)
- History of newly identified major depressive disorder within eight weeks before Screening Visit (DSM-IV-TR) (see also exclusion criteria 11 and inclusion criteria 5)
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- Any significant systemic illness or unstable medical condition that could lead to difficulties complying with the protocol. Patients with a history of systemic cancer within the past two years are excluded
- History of myocardial infarction in the past year or unstable or severe cardiovascular disease, including uncontrolled hypertension
- Any clinically significant laboratory abnormalities on the battery of screening tests (hematology, blood chemistry, urinalysis, ECG, chest x-ray (if available))
- Uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA1c >10.0)
- Use of any concomitant medication that could affect functioning of the CNS or interfere with efficacy assessment.
- Patients who in the Investigator's opinion would not comply with study procedures
- Patients with fragile or thin veins who may not be able to receive many i.v. infusions
- Patients who in the past have not tolerated treatment with 10 mg donepezil or treatment with a corresponding dose of another cholinesterase inhibitor
- Patients with history of any epileptic seizure
- Patients with known or suspected hypersensitivity to Cerebrolysin, donepezil hydrochloride, piperidine derivates or any of the IMPs' excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cerebrolysin and Donepezil: A Randomized, Double-blind, Controlled Trial on Efficacy and Safety in Patients With Mild to Moderate Alzheimer's Disease
The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to donepezil in patients with mild to moderate dementia of Alzheimer's Type (DAT). In addition, a traditional approach will be taken based on the evaluation of the separate risk and benefit domains in comparison with donepezil.
Global risk-benefit as compared to donepezil will be analyzed by determining whether the Cerebrolysin group shows a statistically significant non-inferiority with regard to the combined primary safety and efficacy endpoints (weighted multivariate ensemble). The endpoints will be combined by a global multivariate non-parametric procedure, weighting the safety and efficacy part 50:50.
Read the detailed description
This phase IIIb/IV trial involves patients with mild to moderate Alzheimer's Disease in Europe, Canada and Latin America and is designed as a prospective, randomized, double-blind, active-controlled, parallel-group, multicenter, double-dummy trial.
The study endpoint is after 24 weeks. In total, five visits are scheduled in this trial and a follow-up phone call is performed 4 weeks after Visit 5 (Week 24).
The first visit (Screening Visit, Visit 1) identifies participants who are eligible for and interested in this trial.Efficacy and safety parameters are assessed at the Baseline Visit (Visit 2), in Week 6-7 (Visit 3), Week 14-15 (Visit 4) and Week 24 (Visit 5).
- Conditions
- Alzheimer Disease
- Being tested
- Cerebrolysin, Donepezil
- Keywords
- DAT Study
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Also called Cognicer, Renacenz
Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20.
Placebo for donepezil:1 tablet per day from TC 1 Day 1 on and 2 tablets per day from Visit 3 - Visit 5, p.o.
DonepezilDrug
Also called Other names:, e.g. Aricept, Donesyn
5-10 mg donepezil: 1x5 mg donepezil as 1 tablet per day from TC 1 Day 1 on and 2x5 mg donepezil as 2 tablets from Visit 3- Visit 5, p.o.
Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20.
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin Verum | Experimental | Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). For the infusion 2x10 ml Cerebrolysin (215.2 mg/ml) is diluted with 80 ml 0.9% NaCl (saline) to a total volume of 100 ml, i.v.
Placebo for donepezil: 1 tablet per day from TC 1 Day 1 on and 2 tablets per day from Visit 3 - Visit 5, p.o. Receives: Drug: Cerebrolysin |
| Donepezil Verum | Active comparator | 5-10 mg donepezil: 1x5 mg donepezil as 1 tablet per day from TC 1 Day 1 on and 2x5 mg donepezil as 2 tablets from Visit 3- Visit 5, p.o.
Placebo for Cerebrolysin: 100 ml 0.9% NaCl (saline), i.v. infusion. Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in ADAS-cog. and CIBIC+ score distribution
The ADAS-cog is a psychometric instrument that evaluates cognitive impairment in the assessment of Alzheimer's disease (memory, attention, reasoning, language, orientation and praxis).
The CIBI+ is a global rating measure which covers the categories general, mental/cognitive state, behavior, and activities of daily living.
Measured: at Week 24
Secondary outcomes (3)
Adverse events
descriptive analysis of number, intensity, relation to study medication and action taken
Measured: at Week 24
Vital signs
descriptive analysis of baseline-changes of blood pressure, heart rate, respiration rate, body temperature and weight
Measured: at Week 24
Laboratory tests
descriptive analysis of baseline-changes of hematology (e.g. red blood cell count, hematocrit, hemoglobin levels, mean corpuscular volume, mean corpuscular hemoglobin), blood chemistry (e.g. glucose, total cholesterol, high density lipoprotein cholesterol) and urinalysis (glucose, bilirubin, ketones, density, blood, pH, protein, nitrites and leukocytes)
Measured: at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ever Neuro Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dieter Meier, MD, Study director, Ever Neuro Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822951
- Sponsor's protocol ID
- EVE-AT-0412
- Other IDs
- 2012-004944-31
- Acronym
- DAT
- Status last verified
- Oct 2015
- First submitted
- 25 Mar 2013
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alvarez XA, Cacabelos R, Laredo M, Couceiro V, Sampedro C, Varela M, Corzo L, Fernandez-Novoa L, Vargas M, Aleixandre M, Linares C, Granizo E, Muresanu D, Moessler H. A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease. Eur J Neurol. 2006 Jan;13(1):43-54. doi: 10.1111/j.1468-1331.2006.01222.x.
PubMed 16420392Panisset M, Gauthier S, Moessler H, Windisch M; Cerebrolysin Study Group. Cerebrolysin in Alzheimer's disease: a randomized, double-blind, placebo-controlled trial with a neurotrophic agent. J Neural Transm (Vienna). 2002 Jul;109(7-8):1089-104. doi: 10.1007/s007020200092.
PubMed 12111446Ruether E, Husmann R, Kinzler E, Diabl E, Klingler D, Spatt J, Ritter R, Schmidt R, Taneri Z, Winterer W, Koper D, Kasper S, Rainer M, Moessler H. A 28-week, double-blind, placebo-controlled study with Cerebrolysin in patients with mild to moderate Alzheimer's disease. Int Clin Psychopharmacol. 2001 Sep;16(5):253-63. doi: 10.1097/00004850-200109000-00002.
PubMed 11552768Bae CY, Cho CY, Cho K, Hoon Oh B, Choi KG, Lee HS, Jung SP, Kim DH, Lee S, Choi GD, Cho H, Lee H. A double-blind, placebo-controlled, multicenter study of Cerebrolysin for Alzheimer's disease. J Am Geriatr Soc. 2000 Dec;48(12):1566-71. doi: 10.1111/j.1532-5415.2000.tb03865.x.
PubMed 11129744Alvarez XA, Cacabelos R, Sampedro C, Aleixandre M, Linares C, Granizo E, Doppler E, Moessler H. Efficacy and safety of Cerebrolysin in moderate to moderately severe Alzheimer's disease: results of a randomized, double-blind, controlled trial investigating three dosages of Cerebrolysin. Eur J Neurol. 2011 Jan;18(1):59-68. doi: 10.1111/j.1468-1331.2010.03092.x.
PubMed 20500802Xiao S, Yan H, Yao P. Efficacy of Cerebrolysin in patients with Alzheimer's disease. Clin. Drug Invest. 2000; 19:43-53.
Ruther E, Ritter R, Apecechea M, Freytag S, Windisch M. Efficacy of the peptidergic nootropic drug cerebrolysin in patients with senile dementia of the Alzheimer type (SDAT). Pharmacopsychiatry. 1994 Jan;27(1):32-40. doi: 10.1055/s-2007-1014271.
PubMed 8159781
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cerebrolysin and Donepezil: A Randomized, Double-blind, Controlled Trial on Efficacy and Safety in Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01822951
- Acronym / sponsor ID
- DAT / EVE-AT-0412
- Conditions
- Alzheimer Disease
- Keywords
- DAT Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ever Neuro Pharma GmbHIndustry (pharma, biotech, devices)
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to donepezil in patients with mild to moderate dementia of Alzheimer's Type (DAT). In addition, a traditional approach will be taken based on the evaluation of the separate risk and benefit domains in comparison with donepezil.
Global risk-benefit as compared to donepezil will be analyzed by determining whether the Cerebrolysin group shows a statistically significant non-inferiority with regard to the combined primary safety and efficacy endpoints (weighted multivariate ensemble). The endpoints will be combined by a global multivariate non-parametric procedure, weighting the safety and efficacy part 50:50.
Detailed description
This phase IIIb/IV trial involves patients with mild to moderate Alzheimer's Disease in Europe, Canada and Latin America and is designed as a prospective, randomized, double-blind, active-controlled, parallel-group, multicenter, double-dummy trial.
The study endpoint is after 24 weeks. In total, five visits are scheduled in this trial and a follow-up phone call is performed 4 weeks after Visit 5 (Week 24).
The first visit (Screening Visit, Visit 1) identifies participants who are eligible for and interested in this trial.Efficacy and safety parameters are assessed at the Baseline Visit (Visit 2), in Week 6-7 (Visit 3), Week 14-15 (Visit 4) and Week 24 (Visit 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin Verum | Experimental | Drug: CerebrolysinIntravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). For the infusion 2x10 ml Cerebrolysin (215.2 mg/ml) is diluted with 80 ml 0.9% NaCl (saline) to a total volume of 100 ml, i.v. Placebo for donepezil: 1 tablet per day from TC 1 Day 1 on and 2 tablets per day from Visit 3 - Visit 5, p.o. |
| Donepezil Verum | Active comparator | Drug: Donepezil5-10 mg donepezil: 1x5 mg donepezil as 1 tablet per day from TC 1 Day 1 on and 2x5 mg donepezil as 2 tablets from Visit 3- Visit 5, p.o. Placebo for Cerebrolysin: 100 ml 0.9% NaCl (saline), i.v. infusion. Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female patients ≥50 years of age
- Diagnosis of probable mild to moderate Alzheimer's disease according to DSM-IV-TR and NINCDS-ADRDA criteria (see section 18.2.1)
- Screening MMSE score between 15 and 24, both inclusive
- Modified Hachinski Ischemic score of ≤4
- Hamilton Depression Scale score ≤10
Key exclusion criteria (16 listed)
- Any abnormalities associated with significant central nervous disease other than Alzheimer's Disease
- Severe psychotic features, confusion, agitation or behavioral problems within the last three months that could lead to difficulties complying with the protocol
- Delusional symptoms are often characteristic of Alzheimer's disease, but patients with symptoms so pronounced that they warrant an alternative psychiatric diagnosis are excluded
- History of alcohol or substance abuse or dependence within the past two years (DSM-IV-TR criteria, see also sections 18.3.1 and 18.3.2)
- History of schizophrenia, schizoaffective disorder, bipolar affective disorder (DSM-IV-TR criteria)
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 |
|---|---|---|
| CerebrolysinAlso: Cognicer, RenacenzIntravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20. Placebo for donepezil:1 tablet per day from TC 1 Day 1 on and 2 tablets per day from Visit 3 - Visit 5, p.o. | Drug | Cerebrolysin Verum |
| DonepezilAlso: Other names:, e.g. Aricept, Donesyn5-10 mg donepezil: 1x5 mg donepezil as 1 tablet per day from TC 1 Day 1 on and 2x5 mg donepezil as 2 tablets from Visit 3- Visit 5, p.o. Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20. | Drug | Donepezil Verum |
Primary outcome
Change from Baseline in ADAS-cog. and CIBIC+ score distribution
Time frame: at Week 24
The ADAS-cog is a psychometric instrument that evaluates cognitive impairment in the assessment of Alzheimer's disease (memory, attention, reasoning, language, orientation and praxis). The CIBI+ is a global rating measure which covers the categories general, mental/cognitive state, behavior, and activities of daily living.
3 secondary outcomes
Adverse events
Time frame: at Week 24
Vital signs
Time frame: at Week 24
Laboratory tests
Time frame: at Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
- Background: PubMed 16420392Alvarez XA, Cacabelos R, Laredo M, Couceiro V, Sampedro C, Varela M, Corzo L, Fernandez-Novoa L, Vargas M, Aleixandre M, Linares C, Granizo E, Muresanu D, Moessler H. A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease. Eur J Neurol. 2006 Jan;13(1):43-54. doi: 10.1111/j.1468-1331.2006.01222.x.
- Background: PubMed 12111446Panisset M, Gauthier S, Moessler H, Windisch M; Cerebrolysin Study Group. Cerebrolysin in Alzheimer's disease: a randomized, double-blind, placebo-controlled trial with a neurotrophic agent. J Neural Transm (Vienna). 2002 Jul;109(7-8):1089-104. doi: 10.1007/s007020200092.
- Background: PubMed 11552768Ruether E, Husmann R, Kinzler E, Diabl E, Klingler D, Spatt J, Ritter R, Schmidt R, Taneri Z, Winterer W, Koper D, Kasper S, Rainer M, Moessler H. A 28-week, double-blind, placebo-controlled study with Cerebrolysin in patients with mild to moderate Alzheimer's disease. Int Clin Psychopharmacol. 2001 Sep;16(5):253-63. doi: 10.1097/00004850-200109000-00002.
- Background: PubMed 11129744Bae CY, Cho CY, Cho K, Hoon Oh B, Choi KG, Lee HS, Jung SP, Kim DH, Lee S, Choi GD, Cho H, Lee H. A double-blind, placebo-controlled, multicenter study of Cerebrolysin for Alzheimer's disease. J Am Geriatr Soc. 2000 Dec;48(12):1566-71. doi: 10.1111/j.1532-5415.2000.tb03865.x.
- Background: PubMed 20500802Alvarez XA, Cacabelos R, Sampedro C, Aleixandre M, Linares C, Granizo E, Doppler E, Moessler H. Efficacy and safety of Cerebrolysin in moderate to moderately severe Alzheimer's disease: results of a randomized, double-blind, controlled trial investigating three dosages of Cerebrolysin. Eur J Neurol. 2011 Jan;18(1):59-68. doi: 10.1111/j.1468-1331.2010.03092.x.
- BackgroundXiao S, Yan H, Yao P. Efficacy of Cerebrolysin in patients with Alzheimer's disease. Clin. Drug Invest. 2000; 19:43-53.
- Background: PubMed 8159781Ruther E, Ritter R, Apecechea M, Freytag S, Windisch M. Efficacy of the peptidergic nootropic drug cerebrolysin in patients with senile dementia of the Alzheimer type (SDAT). Pharmacopsychiatry. 1994 Jan;27(1):32-40. doi: 10.1055/s-2007-1014271.
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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.
Dieter Meier, MD study director
Ever Neuro Pharma GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerebrolysin and Donepezil in people with Alzheimer Disease, run by Ever Neuro Pharma GmbH at 1 site in Austria.
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 14 inclusion and 16 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: withdrawn, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from Baseline in ADAS-cog. and CIBIC+ score distribution (time frame: at Week 24). 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 NCT01822951, 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 26 Oct 2015.