Phase 2
Completed N=482
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
Source: ClinicalTrials.gov NCT02079909 ↗Enrolled (actual)
482
Serious AEs
14.7%
Results posted
Aug 2018
Primary outcomePrimary: ADAS-cog Change From Baseline to Week 52 — 7.08; 7.45; 7.91 units on a scale — p=0.3919
Summary
The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC.
The secondary objectives are:
* To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events.
* To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADAS-cog Change From Baseline to Week 52 |
7.08; 7.45; 7.91 | 0.3919 |
| PRIMARY CGIC |
5.25; 5.24; 5.22 | 0.7588 |
| SECONDARY ADCS-ADL Change From Baseline to Week 52 |
-10.01; -11.07; -11.29 | 0.3212 |
Eligibility Criteria
Inclusion Criteria
- Male or female (post-menopausal or surgically sterile)
- Patients with Mild to moderate Alzheimer's disease who are receiving donepezil (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system.
- Age 55 to 85 inclusive
- Patients must be living in the community
- Patients must have an eligible informant or study partner (caregiver)
- Patients and eligible informant or study partner (caregiver) must be able to read and understand English.
- Informed consent obtained from both the patient and the caregiver
Exclusion Criteria
- Patients with clinically significant cardiac, hepatic or renal impairment
- Patient have a dementia not of the Alzheimer's type etc (According to the protocol)
- Patients who are taking any drug other than donepezil or rivastigmine transdermal system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine (Razadyne®)
Data sourced from ClinicalTrials.gov (NCT02079909). 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.