Alzheimer's Disease
Conditions
Brief 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.
Interventions
DRUGELND005 (scyllo-inositol)
Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks After 15Dec2009: ELND005 250 mg PO BID for 48 weeks
Sponsors
OPKO Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Subject has no new medical contraindications to continued participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) | 12 months | Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs) |
Countries
Canada, United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Placebo/2000mg BID 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. | 12 |
| 250mg BID/2000 mg BID 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. | 12 |
| 1000mg BID/2000mg BID 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. | 12 |
| 2000mg BID/2000mg BID 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. | 14 |
| Placebo/ELND005 250mg BID 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. | 26 |
| 250 mg/ELND005 250 mg BID 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. | 27 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Enrolled After 15 Dec 2009 | Adverse Event | 0 | 0 | 0 | 0 | 3 | 0 |
| Enrolled After 15 Dec 2009 | Death | 0 | 0 | 0 | 0 | 0 | 1 |
| Enrolled After 15 Dec 2009 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
| Enrolled After 15 Dec 2009 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 4 | 2 |
| Enrolled Prior to 15 Dec 2009 | Adverse Event | 1 | 0 | 0 | 1 | 0 | 0 |
| Enrolled Prior to 15 Dec 2009 | Sponsor Decision | 11 | 12 | 11 | 13 | 0 | 0 |
| Enrolled Prior to 15 Dec 2009 | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|
| Age, Continuous Enrolled prior to 15 Dec 2009 | 76.8 Years STANDARD_DEVIATION 5.51 | 77.0 Years STANDARD_DEVIATION 6.98 | 76.9 Years STANDARD_DEVIATION 6.92 | 69.2 Years STANDARD_DEVIATION 8.51 | NA Years | NA Years | 74.7 Years STANDARD_DEVIATION 7.73 |
| Age, Continuous Participants enrolled after 15 Dec 2009 | NA Years | NA Years | NA Years | NA Years | 71.4 Years STANDARD_DEVIATION 8.77 | 73.0 Years STANDARD_DEVIATION 7.53 | 72.2 Years STANDARD_DEVIATION 8.12 |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 11 participants | 12 participants | 12 participants | 14 participants | 26 participants | 26 participants | 101 participants |
| Region of Enrollment North America | 12 participants | 12 participants | 12 participants | 14 participants | 26 participants | 27 participants | 103 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 5 Participants | 7 Participants | 18 Participants | 19 Participants | 59 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 3 / 14 | 11 / 26 | 15 / 27 |
| serious Total, serious adverse events | 1 / 12 | 1 / 12 | 0 / 12 | 2 / 14 | 5 / 26 | 6 / 27 |
Outcome results
Primary
Treatment Emergent Adverse Events (TEAEs)
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/ELND005 250mg BID | Treatment Emergent Adverse Events (TEAEs) | 21 participants |
| 250 mg/ELND005 250 mg BID | Treatment Emergent Adverse Events (TEAEs) | 23 participants |