Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for Alzheimer's Disease, Down Syndrome, and Alzheimer Disease. It is in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its potential effects on conditions affecting cognition and behavior.
ELND005 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in neurological conditions.
ELND005 is in Phase 2 clinical development. All four clinical trials listed for the drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval for any indication.
ELND005 has completed four Phase 2 clinical trials. These include NCT00568776 in mild to moderate Alzheimer's Disease, NCT00934050 as a long-term follow-up study, NCT01735630 for agitation and aggression in Alzheimer's Disease, and NCT01791725 in young adults with Down Syndrome without dementia.
ELND005 is a distinct investigational compound being developed by Opko Health Inc. It is not identified as being the same as any other marketed or investigational Alzheimer's disease medication. Its mechanism of action and chemical structure differentiate it from other drugs in this therapeutic area.