Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Albumin 5% · 1 trial · 1 indication
ADAS-Cog total score as a change from baseline to 14 months The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment.
ADCS-ADL total score as a change from baseline to 14 months The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome).
| Arm | Type | Description |
|---|---|---|
| High Albumin + Immunoglobulin | EXPERIMENTAL | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
| Low Albumin + Immunoglobulin | EXPERIMENTAL | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
| Low Albumin | EXPERIMENTAL | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period) |
| Control (sham) group | NO_INTERVENTION | Simulated plasma exchange procedure |
| Name | Type | Description |
|---|---|---|
| Albumin 5% | BIOLOGICAL | Therapeutic plasma exchange with human albumin 5% |
| Albumin 20% | BIOLOGICAL | Low volume plasma exchange with human albumin 5% |
| Immunoglobulin | BIOLOGICAL | Intravenous human immunoglobulin 5% |
Main Inclusion Criteria: 1. Males or females between 55-85 years of age at the time of signing of the informed consent document. 2. A diagnosis of Alzheimer's disease (NINCDS-ADRDA criterion), and mini-mental status examination (MMSE) score between \>/=18 and \</=26. 3. Current stable treatment wit...
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Albumin is an investigational therapy being studied for Alzheimer's Disease. In a Phase 2 clinical trial, it was evaluated in combination with immunoglobulin for the treatment of Alzheimer's Disease. The study enrolled 347 participants and has been completed.
Albumin is being studied for Amyotrophic Lateral Sclerosis (ALS). A Phase 2 clinical trial evaluated the efficacy and safety of plasma exchange with albumin in patients with ALS. The study enrolled 13 participants in Spain and has been completed.
Albumin is being developed by Grifols, S.A., a biopharmaceutical company. The company's stock is traded under the ticker symbol GRFS. Grifols is conducting clinical research to evaluate albumin as a potential treatment for neurological conditions.
Albumin is in Phase 2 clinical development. It has been studied in completed Phase 2 trials for both Alzheimer's Disease and Amyotrophic Lateral Sclerosis. The drug is investigational and has not been approved for these indications.
Albumin has been studied in two completed Phase 2 clinical trials. NCT01561053 evaluated albumin and immunoglobulin in Alzheimer's Disease with 347 participants in the United States and Spain. NCT02479802 evaluated plasma exchange with albumin in Amyotrophic Lateral Sclerosis with 13 participants in Spain.
Albumin is the investigational drug being developed by Grifols, S.A. for neurological conditions. The clinical trials NCT01561053 and NCT02479802 are evaluating albumin as a therapeutic intervention for Alzheimer's Disease and Amyotrophic Lateral Sclerosis, respectively.