ELND005 in Patients With Mild to Moderate Alzheimer's Disease

A Phase 2 study testing ELND005 in people with Alzheimer Disease, run by OPKO Health, Inc. at 62 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease (AD). Read more about this study

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Alzheimer Disease
What is being tested?: ELND005
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 353 participants
Where: 62 sitesin 2 countries
Study dates: Dec 2007to May 2010
Phase: Phase 2
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 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of probable AD
Age 50 to 85 years, inclusive
Mini-Mental Status Exam (MMSE) score of 16-26, inclusive
Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
Fluency in English, French, or Spanish
Stable doses of medications (cholinesterase inhibitors and memantine allowed)
Caregiver is able to attend all study visits

Who cannot join

Significant neurological disease other than AD
Major psychiatric disorder
Significant medical illness
History of stroke or seizure
History of a heart attack within the last 2 years
Prior treatment with certain experimental medicines
Presence of pacemakers or foreign metal objects in the eyes, skin, or body that would prevent patient from having MRI scan

Trial locations and contacts

62 sites in 2 countries.

Country

City, postcode or hospital

62 sites in 2 countries

United States50 sites

Abington Neurological Associates, Inc.
Abington, Pennsylvania, 19001
Upstate Clinical Research, LLC
Albany, New York, 12205
Neurological Associates of Albany, PC
Albany, New York, 12208
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109
University of Michigan, Taubman Health Care Center, Dept. of Neurology
Ann Arbor, Michigan, 48109
Emory University, Dept. of Neurology
Atlanta, Georgia, 30329
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
Bennington, Vermont, 05201
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Brigham and Women's Hospital, Dept. of Neurology
Boston, Massachusetts, 02115
University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology
Burlington, Vermont, 05405
University of Virginia Health System
Charlottesville, Virginia, 22903
Dekalb Neurology Associates, LLC
Decatur, Georgia, 30033
Brain Matters Research, Inc.
Delray Beach, Florida, 33445
The Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
Margolin Brain Institute
Fresno, California, 93720
Collaborative NeuroScience Network, Inc.
Garden Grove, California, 92845
Alliance for Neuro Research, LLC dba Absher Neurology, PA
Greenville, South Carolina, 29615
Sunrise Clinical Research, Inc
Hollywood, Florida, 33021
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, 46202
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, 66160
University of Nevada School of Medicine
Las Vegas, Nevada, 89102
UCLA Alzheimer's Disease Center, Dept. of Neurology
Los Angeles, California, 90095
Medford Neurological and Spine Clinic
Medford, Oregon, 97504
Miami Jewish Home and Hospital For The Aged
Miami, Florida, 33137
Avision Research Associates, LLC
Miami, Florida, 33173
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Sergievsky Center
New York, New York, 10032
UC Irvine Medical Center
Orange, California, 92868
Compass Research, LLC
Orlando, Florida, 32806
Innovative Clinical Concepts
Paducah, Kentucky, 42003
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
University of Pittsburgh Alzheimer Disease Research Clinic
Pittsburgh, Pennsylvania, 15213
Summit Research Newtwork, Inc.
Portland, Oregon, 97210
Global Medical Institutes
Princeton, New Jersey, 08540
Butler Hospital, Memory and Aging Center
Providence, Rhode Island, 02906
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
AD-CARE, Monroe Community Hospital
Rochester, New York, 14620
University of Utah, Dept. of Neurology
Salt Lake City, Utah, 84108
Radiant Research San Antonio
San Antonio, Texas, 78229
UCSF Medical Center, Dept. of Neurology
San Francisco, California, 94143
Roskamp Institute
Sarasota, Florida, 34243
Sun Health Research Institute
Sun City, Arizona, 85351
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, 33617
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623
University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson, Arizona, 85724
Georgetown University Medical Center, Dept. of Neurology
Washington D.C., District of Columbia, 20057
Premiere Research Institute
West Palm Beach, Florida, 33407

Other trials in United States

Canada12 sites

Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Neuro-Rive-Sud Memory Clinic
Greenfield Park, Quebec, J4V 2J2
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology
London, Ontario, N6A 4V2
Parkwood Hospital
London, Ontario, N6C 5J1
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
Montreal, Quebec, H1T 2M4
Sisters of Charity of Ottawa Health Service
Ottawa, Ontario, K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H 2P4
Toronto Memory Program
Toronto, Ontario, M3B 2S7
Whitby Mental Health Memory Clinic
Toronto, Ontario, M5T 2S8
Gerontion Research, Inc.
Toronto, Ontario, M6M 3Z5
University of British Columbia Hospital, Division of Neurology
Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease

The purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease (AD).

Read the detailed description

ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for AD. ELND005 may prevent or inhibit the build up of amyloid protein in the brains of AD patients.

This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months.

Conditions: Alzheimer Disease
Being tested: Placebo Control, ELND005
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo ControlDrug
Also called scyllo-inositol
ELND005 matched placebo capsules for oral administration, bid for 78 weeks
ELND005Drug
ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
ELND005Drug
Also called scyllo-inositol
ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
ELND005Drug
Also called scyllo-inositol
ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks

Study groups in NCT00568776
Study group	Role	What they receive
1	Placebo comparator	Not described Receives: Drug: Placebo Control
2	Active comparator	Not described Receives: Drug: ELND005
3	Active comparator	Not described Receives: Drug: ELND005
4	Active comparator	Not described Receives: Drug: ELND005

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)
The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
Measured: Baseline and 78 weeks
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)
The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
Measured: Baseline and 78 weeks
Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)
The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
Measured: Baseline and 78 weeks
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)
The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
Measured: Baseline and 78 weeks

Secondary outcomes (3)

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)
The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.
Measured: Baseline and 78 weeks
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)
The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.
Measured: Baseline and 78 weeks
Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)
The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.
Measured: Baseline and 78 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007May 2010

First posted6 Dec 2007 (estimated)
Study startDec 2007
Primary completionMay 2010
Study completionMay 2010

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 353 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00568776
Sponsor's protocol ID: ELND005-AD201
Status last verified: Oct 2019
First submitted: 4 Dec 2007
Last updated: 1 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease
ClinicalTrials.gov ID: NCT00568776
Acronym / sponsor ID: ELND005-AD201
Conditions: Alzheimer Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 353 participants (actual)
Lead sponsor: OPKO Health, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 6 Dec 2007 (estimated)
Results: Posted 29 Mar 2012

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 evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease (AD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Placebo comparator	Drug: Placebo Control
2	Active comparator	Drug: ELND005
3	Active comparator	Drug: ELND005
4	Active comparator	Drug: ELND005

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of probable AD
Age 50 to 85 years, inclusive
Mini-Mental Status Exam (MMSE) score of 16-26, inclusive
Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
Fluency in English, French, or Spanish

Key exclusion criteria (7 listed)

Significant neurological disease other than AD
Major psychiatric disorder
Significant medical illness
History of stroke or seizure
History of a heart attack within the last 2 years

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
Placebo ControlAlso: scyllo-inositolELND005 matched placebo capsules for oral administration, bid for 78 weeks	Drug	1
ELND005ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks	Drug	4
ELND005Also: scyllo-inositolELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks	Drug	2
ELND005Also: scyllo-inositolELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks	Drug	3

Primary outcome

Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)
Time frame: Baseline and 78 weeks
The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)
Time frame: Baseline and 78 weeks
The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)
Time frame: Baseline and 78 weeks
The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)
Time frame: Baseline and 78 weeks
The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.

3 secondary outcomes

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Time frame: Baseline and 78 weeks
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Time frame: Baseline and 78 weeks
Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Time frame: Baseline and 78 weeks

Results and safety

Results posted to the registry on 29 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo BID	83	53
ELND005 250 mg BID	88	52
ELND005 1000 mg BID	89	15
ELND005 2000 mg BID	91	19

Primary outcome: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)

Time frame: Baseline and 78 weeks. Mean (Standard Error). Unit: Scores on a Scale

Measure	Placebo BID n = 82	ELND005 250 mg BID n = 84	ELND005 1000 mg BID n = 0	ELND005 2000 mg BID n = 0
Value	-0.383 (0.075)	-0.350 (0.074)	–	–

Placebo BID vs ELND005 250 mg BID: Mean Difference (Final Values): 0.03 (95% CI -0.14 to 0.21), p = 0.71, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

Primary outcome: Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)

Time frame: Baseline and 78 weeks. Mean (Standard Error). Unit: Scores on a Scale

Measure	Placebo BID n = 47	ELND005 250 mg BID n = 49	ELND005 1000 mg BID n = 0	ELND005 2000 mg BID n = 0
Value	-0.369 (0.093)	-0.222 (0.095)	–	–

Placebo BID vs ELND005 250 mg BID: Mean Difference (Final Values): 0.15 (95% CI -0.06 to 0.36), p = 0.17, Mixed Models Analysis

Population analysed: Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.

Primary outcome: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)

Time frame: Baseline and 78 weeks. Mean (Standard Error). Unit: Scores on a Scale

Measure	Placebo BID n = 82	ELND005 250 mg BID n = 84	ELND005 1000 mg BID n = 0	ELND005 2000 mg BID n = 0
Value	-9.467 (1.641)	-10.861 (1.604)	–	–

Placebo BID vs ELND005 250 mg BID: Mean Difference (Final Values): -1.39 (95% CI -5.41 to 2.62), p = 0.49, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.

Primary outcome: Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)

Time frame: Baseline and 78 weeks. Mean (Standard Error). Unit: Scores on a Scale

Measure	Placebo BID n = 47	ELND005 250 mg BID n = 49	ELND005 1000 mg BID n = 0	ELND005 2000 mg BID n = 0
Value	-9.635 (1.779)	-8.987 (1.760)	–	–

Placebo BID vs ELND005 250 mg BID: Mean Difference (Final Values): 0.65 (95% CI -3.73 to 5.03), p = 0.77, Mixed Models Analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reported adverse events include events starting at or after Screening to Week 84. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo BID	11 of 83 (13.3%)	48 of 83 (57.8%)	Not reported
ELND005 250 mg BID	19 of 88 (21.6%)	46 of 88 (52.3%)	Not reported
ELND005 1000 mg BID	20 of 89 (22.5%)	45 of 89 (50.6%)	Not reported
ELND005 2000 mg BID	21 of 91 (23.1%)	57 of 91 (62.6%)	Not reported

Limitations and caveats (from the sponsor): The two high dose groups of ELND005 were discontinued before study end, so the efficacy analysis was based only on placebo and ELND005 250 mg bid groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

62 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ELND005 in people with Alzheimer Disease, run by OPKO Health, Inc. at 62 sites in 2 countries.

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 7 inclusion and 7 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2012). 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?

Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) (time frame: Baseline and 78 weeks). The study lists 4 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 NCT00568776.

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 1 Nov 2019.