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AZD5213 · 5 trials · 5 indications
Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.
Each healthy volunteer in the main panel will complete 3 PET measurements using radioligand; one at baseline and 2 after treatment with AZD5213.
| Arm | Type | Description |
|---|---|---|
| AZD5213 doseA | EXPERIMENTAL | AZD5213 doseA daily |
| AZD5213 doseB | EXPERIMENTAL | AZD 5213 doseB daily |
| AZD5213 doseC | EXPERIMENTAL | AZD5213 doseC daily |
| Placebo | PLACEBO_COMPARATOR | Placebo daily |
| Active | EXPERIMENTAL | Each cohort will have 6 subjects that will receive AZD5213 |
| Pilot panel | EXPERIMENTAL | \[11C\]AZ12807110 distribution and kinetics |
| Main panel | EXPERIMENTAL | Histamine receptor occupancy reached by AZD5213 |
| 1 | EXPERIMENTAL | AZD5213 (dose escalating) |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| AZD5213 | DRUG | AZD5213 doseA daily |
| Placebo | OTHER | Placebo tablet daily |
| [11C]AZ12807110 | OTHER | Radioligand |
| Placebo to AZD5213 | DRUG | - |
Inclusion Criteria: * Patient and study partner to sign informed consent before initiation of any study-related procedures. * Clinical diagnosis of Alzheimers (AD) or mild cognitive impairment (MCI) disease. * Single caregiver for at least 6 months prior to Screening, capable of accompanying the pa...
AZD5213 is an investigational small molecule being studied for mild cognitive impairment, mild Alzheimer's disease, and painful diabetic neuropathy. It has also been evaluated in healthy volunteers for tolerability and for brain distribution of the radioligand [11C]AZ12807110. The drug is in clinical development and is not approved by the FDA.
AZD5213 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of AZD5213 in the United States and Sweden.
AZD5213 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug, meaning it is not yet approved by regulatory authorities. The completed trials include Phase 1 studies in healthy volunteers and Phase 2 studies in patients with mild cognitive impairment, mild Alzheimer's disease, and painful diabetic neuropathy.
AZD5213 has been studied in four completed clinical trials. NCT01121302 was a Phase 1 single ascending dose study in healthy subjects. NCT01194986 was a Phase 1 study of brain distribution and receptor occupancy. NCT01548287 was a Phase 2 study in mild cognitive impairment and mild Alzheimer's disease. NCT01928381 was a Phase 2 study in painful diabetic neuropathy.
No, AZD5213 and AZ12807110 are different compounds. AZ12807110 is a radioligand used in a clinical trial to measure histamine H3 receptor occupancy of AZD5213 in the brain. AZD5213 is the investigational drug being tested for its effects on cognitive impairment and diabetic neuropathy.