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

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Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: T-817MA-L; Drug: T-817MA-H

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02079909

T817MAUS202

Details and patient eligibility

About

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).

Enrollment: 482 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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®)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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482 participants in 3 patient groups, including a placebo group

T-817MA-H

Experimental group

Description:

224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.

Treatment:

Drug: T-817MA-H

T-817MA-L

Experimental group

Description:

224 mg T-817MA once daily

Treatment:

Drug: T-817MA-L

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Placebo