Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)

• Status: Completed
• Trial end date: 2017-05-05
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FUJIFILM Toyama Chemical Co., Ltd.; Toyama Chemical Co., Ltd.
• Collaborator: Alzheimer's Disease Cooperative Study (ADCS)

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®)