Another Drug For Alzheimer's Flops
Another promising handling for Alzheimer's has failed to render whatever evidence that it reduces cognitive turn down too preserves functional abilities inwards patients with mild to moderate Alzheimer's disease.
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Intravenous immunoglobulin (IVIG) failed to halt Alzheimer's inwards patients with mild to moderate Alzheimer's disease.
This is but around other circular of dissapointing too disconcerting tidings for the entire Alzheimer's community worldwide.
According to the World Health Organization (WHO) individual is diagnosed with dementia every iv seconds worldwide.
The lay out ane selling drug for the handling of Alzheimer's, Namenda (memantine), was approved yesteryear the FDA inwards 2003. And, other than Aricept 23mg, every unmarried stage iii clinical lawsuit for the handling of Alzheimer's has failed since that time.
Imagine this.
Memantine was showtime synthesized too patented yesteryear Eli Lilly too Company inwards 1968 too and thus developed yesteryear Merz inwards collaboration with Neurobiological Technologies, Inc. too Children's Hospital, too and thus licensed to Forest Laboratories, Inc. (NYSE: FRX) for the US too Lundbeck for selected European too international markets.
I lost track, but at to the lowest degree xv Alzheimer's clinical trials accept failed since 2004 when Namenda showtime became available for purchase.
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Here is the tidings liberate from Baxter
Baxter Announces Topline Results of Phase III Study of Immunoglobulin for Alzheimer's Disease
Baxter International Inc. (NYSE: BAX) today announced that its Phase III clinical report of immunoglobulin (IG) did non come across its co-primary endpoints of reducing cognitive turn down too preserving functional abilities inwards patients with mild to moderate Alzheimer's disease.
The Gammaglobulin Alzheimer's Partnership (GAP) report was conducted yesteryear Baxter inwards collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical lawsuit consortium supported yesteryear the the States National Institute on Aging inwards the National Institutes of Health.
Topline analyses from the randomized, double-blind, placebo-controlled,
multi-center lawsuit works life that after xviii months of treatment, patients with mild to moderate Alzheimer's affliction taking Baxter's IG handling at either the 400 mg/kg or the 200 mg/kg dose did non demonstrate a statistically meaning deviation inwards the charge per unit of measurement of cognitive turn down every bit compared to placebo (mean 7.4 inwards the 400 mg/kg group, 8.9 inwards the 200 mg/kg group, too 8.4 inwards the placebo group).
Results too did non scream for a statistically meaning alter inwards functional might every bit compared to placebo (mean -11.4 inwards the 400 mg/kg group, -12.4 inwards the 200 mg/kg group, too -11.4 inwards the placebo group).
While the report was non powered to present statistical significance alongside the sub-groups, inwards the pre-specified sub-group analysis, the 400mg/kg handling arm showed a positive, numerical deviation inwards alter from baseline versus placebo inwards knowledge every bit measured yesteryear the Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) too Modified Mini-Mental State (3MS) Examination alongside both moderate patients too carriers of the ApoE4 genetic marker. These differences ranged betwixt xvi pct too 29 percent.*
"The report missed its primary endpoints, even thus nosotros rest interested yesteryear the pre-specified sub-group analyses, peculiarly alongside patients with moderate affliction too those who send a genetic adventure constituent for Alzheimer's disease, 2 patient groups that are inwards slap-up postulate of advances inwards care. H5N1 detailed analysis of the results from the GAP report continues, too nosotros await frontwards to a greater agreement of the total information set," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. "We are grateful for the participation of the patients too physicians inwards the report too for the dedicated back upward of the patients' caregivers."IG was good tolerated inwards the report too no novel security signals were identified associated with handling inwards this patient population, ages 50-89. The virtually mutual adverse reactions (observed inwards at to the lowest degree 5 pct of patients) during handling with IG were rash too decreases inwards hemoglobin. There were no differences inwards the charge per unit of measurement of thromboembolic events inwards the treated groups versus placebo groups. There were 17 serious adverse reactions considered to last treatment-related inwards the report (12 inwards the IG cohorts too 5 inwards the placebo cohort).
Based on these results, Baxter volition reconsider its electrical flow approach for its Alzheimer's programme too volition produce upward one's hear side yesteryear side steps after total information analyses. The electrical flow Baxter studies of IG inwards mild to moderate Alzheimer's affliction volition last discontinued. Additional analyses from the study, including imaging, volition last made available afterward this twelvemonth every bit constituent of a total presentation of the GAP report at the Alzheimer's Association International Conference, July 13-18, 2013 inwards Boston.
The Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) was used to assess cognition, including turn down inwards abilities such every bit retention too linguistic communication (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) inwards activities such every bit eating, walking, grooming, too dressing. The 3MS is a widely used exam for dementia based on the Mini-Mental State Examination (MMSE), but incorporates iv added exam items, to a greater extent than graded scoring, too around other modifications that are designed to address a broader arrive at of cognitive functions too encompass a wider arrive at of difficulty levels (lower scores indicating greater impairment).
"No approved or investigational medication for Alzheimer's affliction has succeeded inwards a clinical lawsuit of this size too duration. Unfortunately, observations of IG seen inwards before phases of studies of Alzheimer's patients did non interpret into a positive outcome inwards the GAP study," said Norman Relkin, M.D., Ph.D., a neurologist from the Weill Cornell Medical College too GAP Study Leader. "Analysis of the total report results is soundless ongoing. I am optimistic that the knowledge nosotros gain from this report volition advance efforts to prepare effective treatments for Alzheimer's disease."The GAP report was the largest placebo-controlled report of immunoglobulin, too was designed to assess the security too effectiveness of Baxter's IG every bit a potential handling for signs too symptoms associated with Alzheimer's disease. The clinical lawsuit treated 390 patients with mild to moderate Alzheimer's affliction across 45 centers inwards the US too Canada. Patients were randomized to handling with Baxter's IG handling at either 400 mg/kg or 200 mg/kg dosing every 2 weeks for xviii months, or placebo. All patients were required to hold their handling regimen of approved medications for Alzheimer's affliction symptom management.
*These differences ranged betwixt xvi pct too 29 percent.
[A information tabular array is available at: www.baxter.com/gap/baxter_gap_study_data_table.pdf].
About IG
Immunoglobulin (IG) is made from purified human plasma, which is collected from salubrious volunteers. The immunoglobulin inwards plasma contains human antibodies that protect the torso against infection, offering of import immunomodulatory too anti-inflammatory properties that assist process rare immune-related too neurological conditions. IG handling is administered on an ongoing footing to assist patients hold adequate levels of antibodies. IG is an investigational handling for Alzheimer's affliction too is non approved for work inwards the handling of the disease.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures too markets products that salvage too sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma too other chronic too shrewd medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise inwards medical devices, pharmaceuticals too biotechnology to produce products that advance patient aid worldwide.
For to a greater extent than information too consummate disclosure take in - http://www.baxter.com/press_room/press_releases/2013/05_07_13_gap_study.html
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