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Also known as ELND005 (scyllo-inositol), Scyllo-inositol
ELND005 · 4 trials · 3 indications
For all AE summaries, if a patient had more than one AE within a preferred term, the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a SOC, the subject was similarly counted only once when reporting results for that SOC.
The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| ELND005 BID | EXPERIMENTAL | ELND005 250 mg BID |
| ELND005 QD | EXPERIMENTAL | ELND005 250 mg QD |
| Placebo | PLACEBO_COMPARATOR | Placebo BID |
| ELND005 | EXPERIMENTAL | ELND005 film coated tablets, BID for 12 weeks |
| 1 | PLACEBO_COMPARATOR | - |
| 2 | ACTIVE_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | - |
| 4 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ELND005 | DRUG | - |
| Placebo | DRUG | - |
| ELND005 (scyllo-inositol) | DRUG | Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks After 15Dec2009: ELND005 250 mg PO BID for 48 weeks |
| Placebo Control | DRUG | ELND005 matched placebo capsules for oral administration, bid for 78 weeks |
Inclusion Criteria: * 18 - 45 years of age * Has an IQ of \> 40 (K-BIT) * Able and willing to have a brain MRI Exclusion Criteria: * Symptoms of dementia or worsening cognition over the past year. * Has a history of hepatitis B, hepatitis C, or HIV
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ELND005 is an investigational small molecule drug being developed by Opko Health Inc. (ticker OPK) for neurological conditions. It has been studied in Alzheimer's disease and Down syndrome. It is a Phase 2 candidate and has not been approved by the FDA.
ELND005 has been studied in Alzheimer's disease, including a Phase 2 trial evaluating it as a treatment for agitation and aggression in patients with Alzheimer's disease. It has also been tested in mild to moderate Alzheimer's disease. It remains investigational and is not approved for any use.
ELND005 is being developed by Opko Health Inc., which trades under the ticker OPK. The company has sponsored Phase 2 clinical trials of the drug in Alzheimer's disease and Down syndrome.
ELND005 is in Phase 2 development. All of its recorded trials are Phase 2 studies, and they have been completed. The drug is investigational and has not received FDA approval.
ELND005 has been evaluated in completed Phase 2 trials, including NCT01791725 in young adults with Down syndrome without dementia, NCT01735630 in agitation and aggression in Alzheimer's disease, NCT00934050, a long-term follow-up study in Alzheimer's disease, and NCT00568776 in mild to moderate Alzheimer's disease.
Yes, ELND005 is also known as scyllo-inositol. Scyllo-inositol is the alternative name for the same investigational small molecule developed by Opko Health Inc. for Alzheimer's disease and Down syndrome.