16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimer's Disease Patients (INSTINCT)

Novartis

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: ENA713

Study type: Interventional

Funder types: Industry

Identifiers

NCT01948791

CENA713BCN05

Details and patient eligibility

About

To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration

Enrollment: 222 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Have a diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
• MMSE score of ≥ 10 and ≤ 26
• The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks
• Be in stable medical condition
• Have signed off informed consent form by patients or his/her legal guardian

Key Exclusion Criteria:

• Severe AD
• Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition
• Attending other clinical trials or taking other clinical trial drugs
• A score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);
• Patients who is using any AChEI or memantine

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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222 participants in 1 patient group

ENA713

Experimental group

Description:

Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.

Treatment:

Drug: ENA713