Results of Phase 3 MAb Trials in Alzheimer Disease Are Hotly Anticipated

For the Internet's edification, the phase 3 trials of MAbs in AD are tabulated by drug (bapineuzumab, solanezumab) and expected completion date.

Although the phase 3 trial of bapineuzumab in APOE ε4 carriers (NCT00575055 or ELN115727-302) reached its estimated completion date last month, the online buzz indicates that Pfizer/Janssen won't publicly release these data until the phase 3 study in noncarriers is completed in August of this year. As readers may recall, the phase 2 data of bapineuzumab suggested that APOE ε4 noncarriers with AD (meaning generally those patients with a lower beta-amyloid burden) fared somewhat clinically better than APOE ε4 carriers and were specifically less likely to develop vasogenic brain edema.

The public release of phase 3 solanezumab data is also expected imminently or at least (I would think) this summer.

Bapineuzumab (Pfizer/Janssen) Phase 3 Trials*

Subjects	Clinical Trials Identifier	Approximate Duration	Estimated Completion Date
1121 APOE ε4 carriers	NCT00575055 (aka ELN115727-302)	1.5 years	April 2012
1300 APOE ε4 noncarriers	NCT00574132 (aka ELN115727-301)	1.5 years	August 2012
Subjects who participated in above studies	NCT00937352	2.5 years or marketing application	June 2012
1100 APOE ε4 carriers	NCT00676143 (aka 3133K1-3001)	1.5 years	June 2013
Subjects who participated in above study	NCT00998764	4 years (extension)	June 2017
1000 APOE ε4 noncarriers	NCT00667810 (aka 3133K1-3000)	1.5 years	June 2014
Subjects who participated in above study	NCT00996918	4 years (extension)	June 2018

Solanezumab (Eli Lilly) Phase 3 Trials**

Subjects	Clinical Trials Identifier	Approximate Duration	Estimated Completion Date
1000 AD patients	NCT00905372	~1.5 years	April 2012
1000 AD patients	NCT00904683	~1.5 years	June 2012
1250 AD patients	NCT01127633 (extension)	2 years	July 2014

In addition, there are several phase 3 studies evaluating IV Ig (eg, Baxter's Gammagard) in patients with AD. Clinical data from these trials aren't expected until 2013 and later.

MAb = monoclonal antibody.

* Owing to a dose-dependent effect on the risk of amyloid-related imaging abnormalities (aka vasogenic edema and microhemorrhages), particularly in APOE ε4 carriers, the dosage of bapineuzumab received by APOE ε4 carriers is now the lowest, tested dosage: 0.5 mg/kg. APOE ε4 noncarriers are receiving 2 dosages of bapineuzumab (0.5 or 1.0 mg/kg) in phase 3 clinical trials.

** Treated patients are receiving one, standard dosage of the MAb.