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23andMe, Genentech Recruiting Patients for Alzheimer's Genetics Research

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By Turna Ray

23andMe and Genentech
are conducting research to uncover the genomic underpinnings of Alzheimer's disease with the hopes of incorporating their findings in the development of a preventative drug.

The two companies have "teamed up to find out how genetics might protect against Alzheimer's disease," 23andMe states in an informational release targeted to customers who may be eligible to participate in this study. "This research could lead to new scientific knowledge or possibly a drug that could prevent or slow [the] disease."

The partners are not discussing the specific terms of their collaboration. "Genentech and 23andMe are working together on the genetics of Alzheimer's disease," a Genentech spokesperson told PGx Reporter. "Beyond that, we are not releasing any details of the study at this time."

Genentech and 23andMe's relationship began when the company launched in 2007. At that time, 23andMe received funding from Genentech, Google, and several VC firms.

There are plenty of critics of the DTC genomics business model, but over the years biopharmaceutical firms and regulatory agencies have often remarked that the genomic and phenotypic datasets housed at companies such as 23andMe could facilitate studies for therapeutic development or help monitor genetically driven adverse reactions to drugs. The 23andMe/Genentech collaboration marks the first publicly known partnership between a consumer genomics firm and a drug developer along these lines.

23andMe has been e-mailing potential study participants to inform of the study and requesting an additional saliva sample if they meet eligibility criteria. In order to participate in this research, individuals must be 75, speak English, and not suffer from memory loss or cognitive impairment. Selected participants must answer questions through a telephone interview, and also have a family member or friend answer questions about their memory.

Study participants will receive $50 once they submit a DNA sample, another $50 after a friend or family member is interviewed, and a free upgrade to the company's latest chip, dubbed V3, if they are not already on it. Study participants can choose whether they wish to know their status for the APOE4 allele, which in previous studies has been linked to increased risk of Alzheimer's disease in carriers.

23andMe in April began reporting APOE genotypes associated with Alzheimer's disease risk to customers who wished to learn this information. In order for customers to get access to this information, they have to acknowledge they understand the limitations of learning their genetic risk for Alzheimer's. This new report is only available to customers who have had their samples analyzed on Illumina's HumanHap 550v3 chip, to which 23andMe upgraded in November (PGx Reporter 04/20/2011).

The consumer genomics firm last year received institutional review board approval for genomic studies that it conducts using customer data. An IRB is an independent panel that ensures that human subjects are protected according to federal guidelines.

With IRB approval, 23andMe gave customers more say in how their genomic data are used for research purposes. Customers can explicitly give consent to submit their de-identified genomic data for research, but if individuals wish to not participate in 23andMe's studies, they will still have access to their genomic information. Customers who do not initially decide to participate in research can give consent later on if they change their minds.

The company last week published the first study culled from its customer base since gaining IRB approval — a genome-wide association study of Parkinson's disease that it conducted with more than 3,400 cases and 29,000 controls in its database. The study, published in PLoS Genetics, identified two novel associations with Parkinson’s and replicated 20 previously identified genetic associations with the disease.

Although 23andMe could use Alzheimer's-related genomic data from customers who have already consented to participate in its research, informing all potential participants of the Genentech study will likely enlist participants who had not originally agreed to submit their data for research.

According to Genentech's pipeline, the firm is currently studying an agent called Anti-Abeta, or MABT5102A, in Phase II studies for Alzheimer's disease. The monoclonal antibody is said to bind to beta amyloid, which is found in the plaque deposits found in the brains of Alzheimer's patients. Researchers believe that beta amyloid plays a critical role in the development of the disease. Genentech is developing Anti-Abeta with the biopharmaceutical company AC Immune.

Clinicaltrials.gov lists Genentech as currently recruiting patients between ages 50 and 80 years old for a study evaluating the efficacy and safety of Anti-Abeta. The primary endpoint of the study is improvement in cognitive function and in dementia rating at 73 weeks from baseline. The description of the study does not discuss genomic analysis.

Outside of the 23andMe/Genentech collaboration, there are other efforts ongoing to advance Alzheimer's prevention drugs in patients who are predicted to be at high risk of getting the disease. For example, researchers led by Allen Roses, director of Duke University's Dean Drug Discovery Institute and CEO at Zinfandel Pharmaceuticals, are currently investigating whether Takeda Pharmaceutical's diabetes drug Actos can delay Alzheimer's onset in people with a high risk of the disease based on age and genetic factors (PGx Reporter 01/12/2011).


Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com.

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