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ENA713

Phase 3

Alzheimer's Disease | Small molecule | Neurology |Novartis AG|Last Updated: Aug 1, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment216

FDA Designations

No designations recorded

Clinical trial landscape

ENA713 · 1 trial · 1 indication

Phase 3 1
NCT01614886Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)Alzheimer's Disease
COMPLETED216 Analytics
PHASE3COMPLETED
Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation
Up to 24 weeks

The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.

Secondary Endpoints

Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)
Baseline, 8,16, and 24 weeks
Change From Baseline in Mini-Mental State Examination (MMSE)
Baseline and 24 weeks
Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly
4, 8, 12,16, 20 and 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1 stepEXPERIMENTAL -
3 stepACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Active ComparatorDRUG1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day.
ENA713DRUG-3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria * A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria * An MMSE score of ≥ 10 and ≤ 20 at baseline Exclusion Criteria: * Any medical or neurological conditions other than AD t...

Countries:Japan
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Frequently asked questions about ENA713

What is ENA713 used for in Alzheimer's Disease?

ENA713 is a small molecule being developed by Novartis AG for the treatment of Alzheimer's Disease. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being studied in patients with Alzheimer's Disease who have a Mini-Mental State Examination (MMSE) score between 10 and 20.

What does ENA713 target?

ENA713 is a small molecule developed for Alzheimer's Disease. The specific molecular target of ENA713 has not been disclosed in available clinical trial information. The drug is being evaluated for its effects on patients with Alzheimer's Disease in a Phase 3 clinical trial setting.

Who makes ENA713?

ENA713 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of ENA713 in patients with Alzheimer's Disease.

What phase is ENA713 in?

ENA713 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a completed Phase 3 clinical trial for the treatment of Alzheimer's Disease.

What clinical trials is ENA713 in?

ENA713 has been studied in one clinical trial registered under the identifier NCT01614886. This was a randomized, double-blind, Phase 3 study conducted in Japan that evaluated the tolerability of two different titration methods of rivastigmine patch in Alzheimer's Disease patients. The trial enrolled 216 participants and has been completed.

Is ENA713 the same as rivastigmine?

ENA713 is being studied in a clinical trial that evaluates rivastigmine patch in Alzheimer's Disease patients. The trial title references rivastigmine patch, suggesting ENA713 may be related to or the same as rivastigmine, though the available information does not explicitly confirm this relationship.