Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

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Coverage from the
Alzheimer's Association International Conference (AAIC) 2017


LONDON — Despite negative findings from the only two phase 3 trials of new drugs on last week's program at the Alzheimer's Association International Conference (AAIC) 2017 in idalopirdine (Lundbeck) and nilvadipine (Archer Pharmaceuticals), experts in the field are still hopeful several new agents for Alzheimer's will become available in the next few years.

Nilvadipine Negative

The Nilvad trial presentation was actually withdrawn at the last minute, but the abstract concluded that "The pre-specified primary analysis for this study was negative, and the results do not indicate benefit of nilvadipine as an add-on treatment" for patients with mild to moderate AD.

The abstract notes that in preclinical studies, nilvadipine was shown to enhance cerebral blood flow and reduce amyloid levels, as well as to have anti-inflammatory and anti-tau properties.
The Nilvad trial was an 18-month, randomized controlled study conducted at 23 centers in Europe and included 511 patients with mild to moderate AD. These participants received either once-daily slow-release nilvadipine 8 mg or placebo.
The coprimary outcomes were progression on the AD Assessment Scale Cognitive-12 (ADAS-Cog12) and on the Clinical Dementia Rating Scale sum of boxes in the intention-to-treat population, in a three-stage gated analysis strategy. The prespecified primary analyses failed to show any treatment benefit on change in ADAS-Cog12 score compared with placebo (P = .44). Secondary outcomes showed no effects of further interest.
Lead investigator of the Nilvad trial Brian Lawlor, MD, Trinity College, Dublin, Ireland, told Medscape Medical News the presentation was withdrawn because the data analysis had not been finalized.
"The paper describing the results is in preparation for submission and will provide more comprehensive information than was in the withdrawn abstract," he said. "We anticipate that presentation of the results at another time is highly likely."

http://www.medscape.com/viewarticle/883484