You are here

Alzheimer’s Drug Fails Mid-Stage Study

TC-1734 not superior to donepezil, researchers find

Disappointing results have been reported from a phase IIb monotherapy clinical trial of TC-1734 (Targacept, Inc.) as a treatment for mild-to-moderate Alzheimer’s disease (AD). The investigational compound is a small molecule that acts selectively on the alpha4beta2 neuronal nicotinic receptor (NNR) subtype.

TC-1734 did not meet the study’s objective of showing superiority over donepezil (Aricept, Eisai/Pfizer), the marketed medication most often prescribed for AS, after 52 weeks of treatment. The trial did not include a placebo arm and was not designed to determine whether TC-1734 is equivalent to donepezil. The co-primary endpoints for the study were measures of cognitive function and global function.

The double-blind, positive-comparator, randomized, parallel-group trial evaluated TC-1734 head-to-head against donepezil in 293 patients with AD. For U.S. regulatory purposes, the Alzheimer’s Disease Assessment Scale–Cognitive subscale 11-item assessment and the Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC) were co-primary endpoints. The study included a 3-week screening period, followed by a 12-month treatment period, during which patients received a fixed dose of TC-1734 (30 mg) or donepezil once daily.

Based on the trial results, Targacept will not invest in further development of this compound.

Sources: Targacept; July 14, 2014; and TC-1734; 2014.

Recent Headlines

Scenesse is new treatment for people with rare, painful light sensitivity disease
Humira, Rituxan top list of drugs that added $5.1 billion to nation's health care bill
Lower court rulings cleared the way for generic versions of the MS drug
Maryland man wins lawsuit that alleges that the company's antipsychotic caused his gynecomastia
Antidepressants, ADHD meds are also used to self-poison
Descovy joins Truvada, another Gilead product, in the HIV prophylaxis market
Data show PTC Therapeutics drug preserves lung function
U.S. maintains measles elimination status as NY outbreak ebbs
Study lists steps that could save close to $300 billion a year