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Encouraging Preliminary Safety Outcomes for a Novel Subcutaneous, Sustained-Release Monthly Implant: Presented at AAT

By Rachel Parratt

HONG KONG -- March 2, 2008 -- Debio 9902 (ZT-1), a potent and selective acetylcholinesterase (AChE-1) inhibitor, has shown promising preliminary safety, according to data presented here in a Late Breaker session at the 10th International Hong Kong/Springfield Pan-Asian Symposium on Advances in Alzheimer Therapy.

On February 29, 2008, 118 patients had been screened/included in BRAINz (Better Recollection for Alzheimer's Patients With Implants of ZT-1), a phase 2b, proof-of-concept study. Seventy-five out of 128 patients have been randomised to receive either repeated monthly subcutaneous injections of a sustained-release implant of Debio 9902 or oral donepezil (Aricept).

"The Data and Safety Monitoring Board (DSMB) meeting held on February 21, 2008, examined safety data from 42 patients having reached study day 85, and recommended continuation of the study with no changes," says United Kingdom chief investigator and presenter David Wilkinson, MD, Director, Memory Assessment and Research Centre (MARC), Moorgreen Hospital, Southampton, United Kingdom.

The Debio 9902 implant (8 mm by 1.3 mm) inserted subcutaneously releases drug for 28 days and has potential advantages for both patients and caregivers. Patients have the possibility of living at home and, with less frequent administration, it has potential for fewer arguments over medication supervision between patients and caregivers.

The primary endpoint for this head-to-head, superiority-designed study includes change in Mini-Mental State Examination (MMSE) score from baseline to week 25.

Secondary endpoints were responder rate (defined by at least a 2-point MMSE improvement), Alzheimer's Disease Assessment Scale-cognitive subscale 11-item Neuropsychiatric Inventory Questionnaire, Instrumental Activities Daily Living, and Patients' Convenience Questionnaire.

Safety measures include monitoring adverse events, vital signs, standard laboratory investigations, and electrocardiogram.

Efficacy and safety results from BRAINz (25 sites in Australia, Canada, and the UK) are expected at the end of 2008 to early 2009.

Funding for this study was provided by Debiopharm.


[Presentation title: The BRAINz Trial: A Novel Approach to Acetylcholinesterase-Inhibitor Treatment for Alzheimer's Disease, New Therapies: Late Breaking News Oral Session]

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