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

Purpose

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).

Condition	Intervention	Phase
Alzheimer's Disease	Drug: RVT-101 35 mg tablets	Phase 3


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Axovant Sciences Ltd.:

Primary Outcome Measures:

Occurrence of adverse events (AEs) and or reported changes in physical examinations, vital signs measurements, electrocardiograms (ECGs), routine laboratory assessments [ Time Frame: Baseline to 12 months or Early Termination ]


Estimated Enrollment:	1150
Study Start Date:	April 2016
Estimated Study Completion Date:	June 2018
Estimated Primary Completion Date:	June 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RVT-101 35 mg tablets once daily, oral tablets	Drug: RVT-101 35 mg tablets once daily, oral tablets

Detailed 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.

Eligibility


Ages Eligible for Study:	50 Years to 86 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02586909

Show 161 Study Locations

Sponsors and Collaborators

Axovant Sciences Ltd.

Investigators


Study Director:	Ilise Lombardo, MD	Axovant Sciences, Inc., Vice President, Clinical Research

More Information


Responsible Party:	Axovant Sciences Ltd.
ClinicalTrials.gov Identifier:	NCT02586909 History of Changes
Other Study ID Numbers:	RVT-101-3002
Study First Received:	October 23, 2015
Last Updated:	June 29, 2017

Keywords provided by Axovant Sciences Ltd.:


Alzheimer's disease RVT-101 donepezil

Additional relevant MeSH terms:


Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on July 14, 2017