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

Alzheimer's Disease Clinical Trial

— INSTINCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948791
• Other study ID #: CENA713BCN05
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2013
• Last updated: August 21, 2016
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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

2. MMSE score of = 10 and = 26

3. The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks

4. Be in stable medical condition

5. Have signed off informed consent form by patients or his/her legal guardian

Exclusion Criteria:

1. Severe AD

2. 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

3. Attending other clinical trials or taking other clinical trial drugs

4. A score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);

5. Patients who is using any AChEI or memantine

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Rivastigmine
As a open-label, one-arm, self-control trial, rivastigmine will be administered from 3mg/d at baseline. Then dose escalation will be made in 3mg/d increments, at a minimun of 4 weeks between dose increases (according to investigator's assessment of individual patient tolerability), to a maximum dose of 12mg/d or the individual's best tolerated dose.

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. The ADAS-cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.	Baseline, 12 weeks and 16 weeks	No
Secondary	Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score	The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement.	Baseline, 12 weeks and 16 weeks	No
Secondary	Change From Baseline in Mini-Mental State Examination (MMSE)	The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.	Baseline/Screening, 12 weeks and 16 weeks	No
Secondary	Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score	The NPI assesses a wide range of behavior problems encountered in dementia patients. The scale includes both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores yields the NPI total score, which ranges from 0 to 120, the lower the score the less severe the symptoms. A negative change score from baseline indicates improvement.	Baseline, 12 weeks and 16 weeks	No
Secondary	Mean Change From Baseline in Caregiver Burden Inventory (CBI) Score	The CBI scale is composed of 24-item multi-dimensional questionnaire measuring caregiver burden with 5 subscales: (a) Time Dependence; (b) Developmental; (c) Behaviour; (d) Physical Burden; (e) Social Burden; (f) Emotional Burden. Scores for each item are evaluated using a 5-point Likert scale ranging from 0 (not at all disruptive) to 4 (very disruptive). It is a self-assessment scale. The range for the total CBI score is 0 to 96. A positive change indicates higher burden for caregiver.	Baseline, 12 weeks and 16 weeks	No
Secondary	Number of Participants Who Discontinued From the Stduy Due to Any Adverse Event (AE)	A secondary assessment of the safety and tolerability was the number of participants who discontinued from the study due to an AE during the study.	Baseline through the end of study (16 weeks)	Yes