Alzheimer's DiseasePhase 2NCT00934050

ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

A Phase 2 study testing ELND005 (scyllo-inositol) in people with Alzheimer's Disease, run by OPKO Health, Inc. at 38 sites in 2 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201. Read more about this study

Who is it for?: Any age
Conditions the study is for: Alzheimer's Disease
What is being tested?: ELND005 (scyllo-inositol)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 38 sitesin 2 countries
Study dates: Jun 2009to Jun 2011
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication.

Who cannot join

Subject has no new medical contraindications to continued participation in the study.

Trial locations and contacts

38 sites in 2 countries.

Country

City, postcode or hospital

38 sites in 2 countries

United States30 sites

Neurological Associates of Albany, PC
Albany, New York, 12208
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109
Emory University, Dept. of Neurology
Atlanta, Georgia, 30329
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
Bennington, Vermont, 05201
Dekalb Neurology Associates, LLC
Decatur, Georgia, 30033
Brain Matters Research
Delray Beach, Florida, 33445
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
Medford Neurological and Spine Clinic
Medford, Oregon, 97504
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510
Columbia University Sergievsky Center
New York, New York, 10032
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
Roskamp Institute
Sarasota, Florida, 34243
Sun Health Research Institute
Sun City, Arizona, 85351
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623
University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson, Arizona, 85724
Premiere Research Institute
West Palm Beach, Florida, 33407

Other trials in United States

Canada8 sites

Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
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
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 Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease

The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.

Conditions: Alzheimer's Disease
Being tested: ELND005 (scyllo-inositol)
Medical subject headings: Alzheimer Disease

What participants receive

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

ELND005 (scyllo-inositol)Drug
Also called scyllo-inositol
Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks
After 15Dec2009: ELND005 250 mg PO BID for 48 weeks

Study groups in NCT00934050
Study group	Role	What they receive
ELND005	Experimental	Not described Receives: Drug: ELND005 (scyllo-inositol)

What is being measured

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

Treatment Emergent Adverse Events (TEAEs)
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: 12 months

Timeline

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

Jun 2009Jun 2011

First posted8 Jul 2009 (estimated)
Study startJun 2009
Primary completionJun 2011
Study completionJun 2011

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's 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00934050
Sponsor's protocol ID: ELND005-AD251
Status last verified: Oct 2019
First submitted: 29 Jun 2009
Last updated: 21 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
ClinicalTrials.gov ID: NCT00934050
Acronym / sponsor ID: ELND005-AD251
Conditions: Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: OPKO Health, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 8 Jul 2009 (estimated)
Results: Posted 13 May 2015

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 long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ELND005	Experimental	Drug: ELND005 (scyllo-inositol)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication.

Key exclusion criteria (1 listed)

Subject has no new medical contraindications to continued participation in the study.

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
ELND005 (scyllo-inositol)Also: scyllo-inositolPrior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks After 15Dec2009: ELND005 250 mg PO BID for 48 weeks	Drug	ELND005

Primary outcome

Treatment Emergent Adverse Events (TEAEs)
Time frame: 12 months
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)

Results and safety

Results posted to the registry on 13 May 2015, 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/ELND005 2000mg BID	12	0
250mg/ELND005 2000mg BID	12	0
1000 mg/ELND005 2000 mg BID	12	0
2000 mg ELND005/ELND005 2000 mg BID	14	0
Placebo/ELND005 250 mg BID	0	0
250 mg/ELND005 250 mg BID	0	0

Primary outcome: Treatment Emergent Adverse Events (TEAEs)

Time frame: 12 months. Number. Unit: participants

Measure	Placebo/ELND005 250mg BID n = 26	250 mg/ELND005 250 mg BID n = 27
Value	21	23

Population analysed: As a result of safety findings, effective 15 December 2009, all 50 patients at the 2000 mg BID dose were withdrawn from the study. Subsequently patients who were on placebo or 250 mg BID in Study AD201 received 250 mg BID in Study AD251. Only Arms who completed the study per the protocol were included in the analysis.

Adverse events

Time frame: Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/ELND005 2000mg BID	1 of 12 (8.3%)	0 of 12 (0%)	Not reported
250mg/ELND005 2000mg BID	1 of 12 (8.3%)	0 of 12 (0%)	Not reported
1000 mg/ELND005 2000 mg BID	0 of 12 (0%)	0 of 12 (0%)	Not reported
2000 mg ELND005/ELND005 2000 mg BID	2 of 14 (14.3%)	3 of 14 (21.4%)	Not reported
Placebo/ELND005 250 mg BID	5 of 26 (19.2%)	11 of 26 (42.3%)	Not reported
250 mg/ELND005 250 mg BID	6 of 27 (22.2%)	15 of 27 (55.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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.

38 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 (scyllo-inositol) in people with Alzheimer's Disease, run by OPKO Health, Inc. at 38 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 1 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: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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. 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 13 May 2015). 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?

Treatment Emergent Adverse Events (TEAEs) (time frame: 12 months). 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 NCT00934050.

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 21 Oct 2019.