ClinicalTrials.Veeva

Menu

12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension

A

Axovant Sciences

Status and phase

Terminated
Phase 3

Conditions

Alzheimer's Disease

Treatments

Drug: RVT-101 35 mg tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT02586909
RVT-101-3002

Details and patient eligibility

About

This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).

Full description

This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Enrollment

1,099 patients

Sex

All

Ages

50 to 86 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completed last on-treatment visit of the lead-in study RVT-101-3001

Exclusion criteria

  • Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,099 participants in 1 patient group

RVT-101 35 mg tablets
Experimental group
Description:
once daily, oral tablets
Treatment:
Drug: RVT-101 35 mg tablets

Trial documents
1

Trial contacts and locations

169

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems