You are here

Alzheimer’s Drug Fails Phase III Study

Immunoglobulin no more effective than placebo (May 7)

A phase III clinical trial of immunoglobulin (IG, Baxter) did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild-to-moderate Alzheimer's disease (AD).

Analyses from the randomized, double-blind, placebo-controlled Gammaglobulin Alzheimer's Partnership (GAP) study found that, after 18 months of treatment, patients with mild-to-moderate AD receiving the IG treatment at either the 400 mg/kg or 200 mg/kg dose did not demonstrate a statistically significant difference in the mean rate of cognitive decline compared with placebo (7.4 in the 400 mg/kg group, 8.9 in the 200 mg/kg group, and 8.4 in the placebo group). The results also did not indicate a statistically significant mean change in functional ability compared with placebo (–11.4 in the 400 mg/kg group, –12.4 in the 200 mg/kg group, and –11.4 in the placebo group).

While the study was not powered to show statistical significance among the subgroups in a pre-specified subgroup analysis, the 400 mg/kg treatment arm showed a positive, numerical difference in the change from baseline in cognition versus placebo, as measured by the Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) and the Modified Mini-Mental State (3MS) examination among both patients with moderate AD and carriers of the ApoE4 genetic marker. These differences ranged between 16% and 29%.

Based on these results, the drug’s developer (Baxter) will discontinue current studies of IG in mild-to-moderate AD.

The GAP trial enrolled 390 patients with mild-to-moderate AD in the U.S. and Canada. The patients were randomly assigned to receive either IG treatment (400 mg/kg or 200 mg/kg) or placebo every 2 weeks for 18 months. All of the patients were required to maintain their treatment regimen of approved medications for AD symptom management.

Source: Baxter; May 7, 2013.

Recent Headlines

Breast Cancer, Gastrointestinal Tumors Most Common Types
Two-Thirds of U.S. Alzheimer’s Cases Are Women, And It’s Not Just Because They Live Longer
Recarbrio Should be Reserved For Limited/No Alternative Antibacterial Treatment Cases
NY Hospitals Required to Implement Protocols in Suspected Cases
Presence of BOK Protein Key for Positive Treatment Response
Patient Access to Inhaler Use Data Could Improve Asthma Management
Overall Survival 4.3 Months’ vs. 1.5 Months for Traditional Regimens