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Trial record 2 of 10 for:    AD201
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ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00934050
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : May 13, 2015
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Intervention Drug: ELND005 (scyllo-inositol)
Enrollment 103
Recruitment Details  
Pre-assignment Details All participants who enrolled in long term follow up prior to 15 Dec 2009 received ELND005 2000 mg BID; due to protocol amendment, all participants who enrolled in long term follow up after 15 Dec 2009 received ELND005 250 mg BID
Arm/Group Title Placebo/ELND005 2000mg BID 250mg/ELND005 2000mg BID 1000 mg/ELND005 2000 mg BID 2000 mg ELND005/ELND005 2000 mg BID Placebo/ELND005 250 mg BID 250 mg/ELND005 250 mg BID
Hide Arm/Group Description In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Period Title: Enrolled Prior to 15 Dec 2009
Started 12 12 12 14 0 0
Completed 0 0 0 0 0 0
Not Completed 12 12 12 14 0 0
Reason Not Completed
Adverse Event             1             0             0             1             0             0
Sponsor Decision             11             12             11             13             0             0
Withdrawal by Subject             0             0             1             0             0             0
Period Title: Enrolled After 15 Dec 2009
Started 0 0 0 0 26 27
Completed 0 0 0 0 19 23
Not Completed 0 0 0 0 7 4
Reason Not Completed
Adverse Event             0             0             0             0             3             0
Death             0             0             0             0             0             1
Lost to Follow-up             0             0             0             0             0             1
Withdrawal by Subject             0             0             0             0             4             2
Arm/Group Title Placebo/2000mg BID 250mg BID/2000 mg BID 1000mg BID/2000mg BID 2000mg BID/2000mg BID Placebo/ELND005 250mg BID 250 mg/ELND005 250 mg BID Total
Hide Arm/Group Description In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 14 26 27 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
 Number Analyzed 12 participants 12 participants 12 participants 14 participants 26 participants 27 participants 103 participants
Enrolled prior to 15 Dec 2009 76.8  (5.51) 77.0  (6.98) 76.9  (6.92) 69.2  (8.51) NA [1]   (NA) NA [1]   (NA) 74.7  (7.73)
Participants enrolled after 15 Dec 2009 NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) 71.4  (8.77) 73.0  (7.53) 72.2  (8.12)
[1]
All participants enrolled after 15 Dec 2009
[2]
All participants enrolled prior to 15 Dec 2009
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 14 participants 26 participants 27 participants 103 participants
Female
5
  41.7%
5
  41.7%
5
  41.7%
7
  50.0%
18
  69.2%
19
  70.4%
59
  57.3%
Male
7
  58.3%
7
  58.3%
7
  58.3%
7
  50.0%
8
  30.8%
8
  29.6%
44
  42.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 12 participants 12 participants 12 participants 14 participants 26 participants 27 participants 103 participants
Hispanic or Latino 1 0 0 0 0 1 2
Not Hispanic or Latino 11 12 12 14 26 26 101
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 12 participants 12 participants 12 participants 14 participants 26 participants 27 participants 103 participants
12 12 12 14 26 27 103
1.Primary Outcome
Title Treatment Emergent Adverse Events (TEAEs)
Hide Description Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/ELND005 250mg BID 250 mg/ELND005 250 mg BID
Hide Arm/Group Description:
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Overall Number of Participants Analyzed 26 27
Measure Type: Number
Unit of Measure: participants
21 23
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).
Adverse Event Reporting Description For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
 
Arm/Group Title Placebo/ELND005 2000mg BID 250mg/ELND005 2000mg BID 1000 mg/ELND005 2000 mg BID 2000 mg ELND005/ELND005 2000 mg BID Placebo/ELND005 250 mg BID 250 mg/ELND005 250 mg BID
Hide Arm/Group Description In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks. In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
All-Cause Mortality
Placebo/ELND005 2000mg BID 250mg/ELND005 2000mg BID 1000 mg/ELND005 2000 mg BID 2000 mg ELND005/ELND005 2000 mg BID Placebo/ELND005 250 mg BID 250 mg/ELND005 250 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo/ELND005 2000mg BID 250mg/ELND005 2000mg BID 1000 mg/ELND005 2000 mg BID 2000 mg ELND005/ELND005 2000 mg BID Placebo/ELND005 250 mg BID 250 mg/ELND005 250 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   1/12 (8.33%)   0/12 (0.00%)   2/14 (14.29%)   5/26 (19.23%)   6/27 (22.22%) 
Cardiac disorders             
Atrial Fibrillation †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%) 
Cardiac Failure Congestive †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%) 
Bradycardia †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/27 (0.00%) 
Infections and infestations             
Klebsiella Sepsis †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%) 
Pneumonia †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%) 
Sepsis †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/27 (3.70%) 
Urinary Tract Infection †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%) 
Injury, poisoning and procedural complications             
Femoral Neck Fracture †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  2/26 (7.69%)  0/27 (0.00%) 
Lumbar Vertebral Fracture †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/27 (3.70%) 
Rib Fracture †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/27 (0.00%) 
Metabolism and nutrition disorders             
Dehydration †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/27 (0.00%) 
Musculoskeletal and connective tissue disorders             
Musculoskeletal Pain †  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Basal Cell Carcinoma †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/27 (3.70%) 
Bladder transitional Cell Carcinoma †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/27 (0.00%) 
Colon Cancer †  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%) 
Nervous system disorders             
Presyncope †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/27 (3.70%) 
Transient Ischaemic Attack †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/27 (0.00%) 
Psychiatric disorders             
Agitation †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/27 (3.70%) 
Confusional State †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders             
Acute Respiratory Failure †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/27 (3.70%) 
Pneumonia Aspiration †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/27 (3.70%) 
Respiratory Failure †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%) 
Vascular disorders             
Hypotension †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/27 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo/ELND005 2000mg BID 250mg/ELND005 2000mg BID 1000 mg/ELND005 2000 mg BID 2000 mg ELND005/ELND005 2000 mg BID Placebo/ELND005 250 mg BID 250 mg/ELND005 250 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   3/14 (21.43%)   11/26 (42.31%)   15/27 (55.56%) 
Gastrointestinal disorders             
Constipation †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  2/26 (7.69%)  2/27 (7.41%) 
Diarrhoea †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  2/26 (7.69%)  1/27 (3.70%) 
Nausea †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  4/26 (15.38%)  1/27 (3.70%) 
Infections and infestations             
Upper Respiratory Tract Infection †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  3/27 (11.11%) 
Urinary Tract Infection †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  3/14 (21.43%)  3/26 (11.54%)  3/27 (11.11%) 
Injury, poisoning and procedural complications             
Fall †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  4/26 (15.38%)  1/27 (3.70%) 
Musculoskeletal and connective tissue disorders             
Back Pain †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  3/27 (11.11%) 
Pain In Extremity †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  2/27 (7.41%) 
Psychiatric disorders             
Agitation †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  2/26 (7.69%)  4/27 (14.81%) 
Insomnia †  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  2/26 (7.69%)  4/27 (14.81%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Abushakra, MD, Chief Medical Officer
Organization: Transition Therapeutics Ireland Limited and Transition Therapeutics USA Inc.
Phone: +1 650 425 6370
EMail: susan.abushakra@tthi.us
Layout table for additonal information
Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT00934050    
Other Study ID Numbers: ELND005-AD251
First Submitted: June 29, 2009
First Posted: July 8, 2009
Results First Submitted: April 22, 2015
Results First Posted: May 13, 2015
Last Update Posted: October 21, 2019