Phase 4
Completed N=222
16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimer's Disease Patients
Source: ClinicalTrials.gov NCT01948791 ↗Enrolled (actual)
222
Serious AEs
3.9%
Results posted
Feb 2017
Primary outcomePrimary: Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) — -2.0 units on a scale — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) |
-2.0 | <0.001 sig |
| SECONDARY Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score |
0.9 | — |
| SECONDARY Change From Baseline in Mini-Mental State Examination (MMSE) |
0.3 | — |
| SECONDARY Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score |
-3.6; -4.0 | — |
| SECONDARY Change From Baseline in Caregiver Burden Inventory (CBI) Score |
-1.4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01948791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.