Expanded Access to Provide SUVN-502 for the Treatment of Subjects With Alzheimer's Disease

NCT ID: NCT03564964

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to SUVN-502 for the treatment of Alzheimer's Disease. Investigator as well as the subject/caregiver must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria.

Subjects will not be evaluated for efficacy and safety during the expanded access.

Conditions

Alzheimer Disease; Dementia; Cognition Disorders

Interventions

SUVN-502

Tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects who have completed the 30 week treatment period of study CTP2S1502HT6 as planned and wish to continue treatment with SUVN-502.
• Subject (or subject's legally acceptable representative) and caregiver must sign the Informed Consent Form (ICF) to participate in the study.

Exclusion Criteria

• Has participated or is participating in any other clinical (investigational) study after completion of CTP2S1502HT6 study.
• Is treated or likely to require treatment during the study with any medication prohibited by this expanded access program.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suven Life Sciences Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EAP1502HT6

Identifier Type: -

Identifier Source: org_study_id