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

NCT01948791 | Completed Phase 4 Results

• 1 other identifier: CENA713BCN05
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; ENA713; Chinese patients; INSTINCT

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)

  The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimer's disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.

  Baseline, Week 16

Secondary Outcomes (4)

• Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score

  Baseline, Week 16

• Change From Baseline in Mini-Mental State Examination (MMSE)

  Baseline, Week 16

• Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score

  Baseline, Week 16

• Change From Baseline in Caregiver Burden Inventory (CBI) Score

  Baseline, Week 16

Study Arms (1)

ENA713

EXPERIMENTAL

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

Drug: ENA713

Interventions

ENA713 DRUG

The following strengths of Rivastigmine capsules were provided: Rivastigmine capsule strengths: 1.5mg, 3mg, 4.5mg. The 6mg dose was administered as one 1.5mg capsule and one 4.5mg capsule, and when necessary, the 3mg dose could also be administered as two 1.5mg capsules. Rivastigmine was administered from 3mg/d at baseline. Then dose escalation was made in 3mg/d increments, at a minimun of 4 weeks between dose increases to a maximum dose of 12mg/d or the individual's best tolerated dose.

Also known as: Rivastigmine

ENA713

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Beijing, 100053, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Of the total recruited subjects, 181 subjects received at least one drug treatment and there were post-baseline safety assessment. They were incorporated into the safety population.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Jianping Jia, MD/PhD

  Department of Neurology, Xuanwu HospitalCapital Medical University, Beijing, P.R.China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 24, 2013
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 13, 2017
• Results First Posted: February 13, 2017

Record last verified: 2016-12

Locations

CN (1)