Corporate Banner
Satellite Banner
Immunology
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Baxter Announces Topline Results of Phase III Study of Immunoglobulin for Alzheimer's

Published: Thursday, May 09, 2013
Last Updated: Thursday, May 09, 2013
Bookmark and Share
Phase III clinical study of immunoglobulin (IG) did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer’s disease.

The Gammaglobulin Alzheimer’s Partnership (GAP) study was conducted by Baxter in collaboration with the Alzheimer’s Disease Cooperative Study (ADCS), a clinical trial consortium supported by the United States National Institute on Aging in the National Institutes of Health.

Topline analyses from the randomized, double-blind, placebo-controlled, multi-center trial found that after 18 months of treatment, patients with mild to moderate Alzheimer's disease taking Baxter's IG treatment at either the 400 mg/kg or the 200 mg/kg dose did not demonstrate a statistically significant difference in the rate of cognitive decline as compared to placebo (mean 7.4 in the 400 mg/kg group, 8.9 in the 200 mg/kg group, and 8.4 in the placebo group). Results also did not indicate a statistically significant change in functional ability as compared to placebo (mean -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 sub-groups, in the pre-specified sub-group analysis, the 400mg/kg treatment arm showed a positive, numerical difference in change from baseline versus placebo in cognition as measured by the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) and Modified Mini-Mental State (3MS) Examination among both moderate patients and carriers of the ApoE4 genetic marker. These differences ranged between 16 percent and 29 percent. [A data table is available at: www.baxter.com/gap/baxter_gap_study_data_table.pdf].

''The study missed its primary endpoints, however we remain interested by the pre-specified sub-group analyses, particularly among patients with moderate disease and those who carry a genetic risk factor for Alzheimer’s disease, two patient groups that are in great need of advances in care. A detailed analysis of the results from the GAP study continues, and we look forward to a greater understanding of the full data set,'' said Ludwig Hantson, Ph.D., president of Baxter’s BioScience business. ''We are grateful for the participation of the patients and physicians in the study and for the dedicated support of the patients’ caregivers.''

IG was well tolerated in the study and no new safety signals were identified associated with treatment in this patient population, ages 50-89. The most common adverse reactions (observed in at least 5 percent of patients) during treatment with IG were rash and decreases in hemoglobin. There were no differences in the rate of thromboembolic events in the treated groups versus placebo groups. There were 17 serious adverse reactions considered to be treatment-related in the study (12 in the IG cohorts and five in the placebo cohort).

Based on these results, Baxter will reconsider its current approach for its Alzheimer’s program and will determine next steps after full data analyses. The current Baxter studies of IG in mild to moderate Alzheimer’s disease will be discontinued. Additional analyses from the study, including imaging, will be made available later this year as part of a full presentation of the GAP study at the Alzheimer’s Association International Conference, July 13-18, 2013 in Boston.

The Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) was used to assess cognition, including decline in abilities such as memory and language (higher scores indicating greater impairment). The Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) was used to assess functional abilities using a 23-item score (lower scores indicating greater impairment) in activities such as eating, walking, grooming, and dressing. The 3MS is a widely used test for dementia based on the Mini-Mental State Examination (MMSE), but incorporates four added test items, more graded scoring, and some other modifications that are designed to address a broader range of cognitive functions and cover a wider range of difficulty levels (lower scores indicating greater impairment).

''No approved or investigational medication for Alzheimer’s disease has succeeded in a clinical trial of this size and duration. Unfortunately, observations of IG seen in earlier phases of studies of Alzheimer’s patients did not translate into a positive outcome in the GAP study,'' said Norman Relkin, M.D., Ph.D., a neurologist from the Weill Cornell Medical College and GAP Study Leader. ''Analysis of the full study results is still ongoing. I am optimistic that the knowledge we gain from this study will advance efforts to develop effective treatments for Alzheimer’s disease.''

The GAP study was the largest placebo-controlled study of immunoglobulin, and was designed to assess the safety and effectiveness of Baxter’s IG as a potential treatment for signs and symptoms associated with Alzheimer’s disease. The clinical trial treated 390 patients with mild to moderate Alzheimer’s disease across 45 centers in the U.S. and Canada. Patients were randomized to treatment with Baxter’s IG treatment at either 400 mg/kg or 200 mg/kg dosing every two weeks for 18 months, or placebo. All patients were required to maintain their treatment regimen of approved medications for Alzheimer’s disease symptom management.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,400+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Baxter Announces Biologics Capacity Expansion
Plan includes new manufacturing site in Georgia and creation of more than 2,000 U.S. jobs.
Friday, April 20, 2012
Scientific News
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
COPD Linked to Increased Bacterial Invasion
Persistent inflammation in COPD may result from a defect in the immune system that allows airway bacteria to invade deeper into the lung.
Finding Factors That Protect Against Flu
A clinical trial examining the body’s response to seasonal flu suggests new approaches for evaluating the effectiveness of seasonal flu vaccines.
Vaccinations Are More Effective When Administered In The Morning
Research from the University of Birmingham shows that influenza vaccinations have more protective responses when administered in the morning.
Secrets of a Deadly Virus Family Revealed
Scripps Research scientists uncover the glycoprotein structure of LCMV. The findings could guide development of treatments for Lassa fever.
Cytokine Triggers Immune Response at Expense of Blood Renewal
Research highlights promise of Anti-IL-1 drugs to treat chronic inflammatory disease.
Reduced Immune Response Causes Flu Deaths in Older Adults
Yale study suggests that immune response to flu causes death in older people, not the virus.
Exposure To Routine Viruses Makes Mice Better Test Subjects
Study shows that infections make mouse immune system act more like that in humans.
Immune Booster Tested in Advanced Merkel Cell Cancer
The immunotherapy drug produced durable responses in many patients.
Factors Influencing Influenza Vaccine Effectiveness Uncovered
The long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited, new research suggests.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!