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INSTINCT

CompletedPhase 4Results posted

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

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

Lead sponsor

Novartis Pharmaceuticals

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

222

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCENA713BCN05

NCT IDNCT01948791

Timeline

Milestones

Study first posted2013-09-24estimated

Study start2014-08 (month precision)

Primary completion2015-09actual (month precision)

Study completion2015-09actual (month precision)

Last update posted2017-02-13actual

Results first posted2017-02-13actual

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Global cognition

4 endpoints

Primary/protocol endpoint

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

Time frame:Baseline, Week 16

ADAS-Cog

change from baseline, improvement

Primary/registry result

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

Time frame:Baseline, Week 16

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Reported bounds
ENA713n=151 Participants	-2.0	--3.0 - 1.1

p<0.001t-test, 1 sided

Secondary/protocol endpoint

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

Time frame:Baseline, Week 16

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 16

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Reported bounds
ENA713n=151 Participants	0.3	--0.4 - 0.8

Function / daily living

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 16

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 16

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Reported bounds
ENA713n=151 Participants	0.9	--0.5 - 2.3

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline, Week 16

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline, Week 16

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Reported bounds
ENA713NPI-10n=151 Participants	-3.6	--5.3 - -1.9
NPI-12n=151 Participants	-4.0	--6.2 - -1.9

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Caregiver Burden Inventory (CBI) Score

Time frame:Baseline, Week 16

change from baseline, improvement

Secondary/registry result

Change From Baseline in Caregiver Burden Inventory (CBI) Score

Time frame:Baseline, Week 16

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Reported bounds
ENA713n=151 Participants	-1.4	--3.1 - 0.4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.