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Completed

NCT Number: NCT02079909

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

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).

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banner Alzheimer's Institute, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®)

Treatment and study plan

T-817MA-H

Drug

224 mg or 448 mg T-817 MA once daily

T-817MA-L

Drug

224 mg T-817 MA once daily

Placebo

Drug

Placebo

Primary outcomes

  1. ADAS-cog Change From Baseline to Week 52

    Time frame: Baseline and 52 weeks

    The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).

  2. CGIC

    Time frame: 52 weeks

    The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.

Secondary outcomes

  1. ADCS-ADL Change From Baseline to Week 52

    Time frame: Baseline and 52 weeks

    The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment.

Sponsors and collaborators

Lead sponsor

FUJIFILM Toyama Chemical Co., Ltd.

Industry

Collaborators

  • Alzheimer's Disease Cooperative Study (ADCS)

Registry information

Official study title

A Phase 2 Multi-center, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2014
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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