Learn more about our ongoing INFRONT-3 trial of AL001 for the treatment of frontotemporal dementia (FTD).
Learn more about our ongoing INVOKE trial of AL002 for the treatment of Alzheimer’s disease.
Learn more about our ongoing INTERCEPT trial of AL003 for the treatment of Alzheimer’s disease.
Frontotemporal dementia (FTD) is a form of dementia found most frequently in individuals less than 65 years old at time of diagnosis. FTD affects roughly 50,000 to 60,000 individuals in the United States and roughly 110,000 individuals in the European Union. FTD is a rapidly progressing degenerative syndrome characterized by prominent cognitive dysfunction, behavioral and personality changes, and language deficits. The average life expectancy in FTD patients is seven to 10 years after the onset of symptoms.
The Association for Frontotemporal Degeneration
Alzheimer’s disease is a degenerative brain disease and the most common form of dementia. It is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually the ability to carry out the simplest tasks. In most people with Alzheimer’s, symptoms first appear in their mid-60s. Estimates vary, but experts suggest that more than 5.5 million Americans may have Alzheimer’s.
Alzheimer’s Association for AD
Alector’s Expanded Access Policy
Alector is committed to developing safe and effective therapies to transform the lives of patients with neurodegenerative diseases. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.
Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.
A number of factors consistent with the US Food and Drug Administration (US FDA) and other regulatory agencies’ guidelines should be taken into account when considering expanded access. They include:
- The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
- Ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
- Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients
At this time, participation in one of our clinical trials is the only way to access our investigational therapies. If you have additional questions, please speak with your physician or contact Alector directly at clinicaltrials@Alector.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
In line with the 21st Century Cures Act, Alector may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.