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

NCT03564964 | Unknown

• 1 other identifier: EAP1502HT6
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

SUVN-502; Expanded Access

Interventions

SUVN-502 DRUG

Tablet

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suven Life Sciences Limited: lead

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognition Disorders

Interventions

1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 21, 2018
• Last Updated: September 29, 2020

Record last verified: 2020-09