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Alzheimer's DiseasePhase 3NCT02327182

Safety Study of MT-4666 in Subjects With Alzheimer's Disease

A Phase 3 study testing MT-4666 in people with Alzheimer's Disease, run by Tanabe Pharma Corporation at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD). Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
MT-4666
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteJapan
Study dates
Dec 2014to Oct 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Probable Alzheimer's disease consistent with the National Institute on Aging and the Alzheimer's Association Criteria for Diagnosis of Alzheimer's Disease (McKhann et al. 2011).
  • MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline.
  • Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening
  • Appropriate caregiver available
  • Subject living at home or in facilities who do not require continuous (24-hour) nursing care.

Who cannot join

  • Diagnosis of any other disease which may cause dementia
  • Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years
  • History of or current diagnosis of any psychosis
  • History of myocardial infarction or unstable angina within six months before screening
  • History of cerebrovascular disorder within 18 months before screening
  • complication of hepatic disorder or renal dysfunction

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Investigational site

    Osaka, Kansai

Other trials in Japan

About this study

Official title: A Long-Term Safety Study of MT-4666 in Patients With Mild to Moderate Alzheimer's Disease (AD)

The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD).

Being tested
MT-4666
Keywords
MT-4666, α7 nicotinic acetylcholine receptor agonist, Alzheimer's Disease, Cognitive function, Dementia, Central Nervous System Agents
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MT-4666Drug

Study groups in NCT02327182
Study groupRoleWhat they receive
MT-4666 low doseExperimentalLow Dose, Tablet, Once Daily, For 52 Weeks
Receives: Drug: MT-4666
MT-4666 high doseExperimentalHigh Dose, Tablet, Once Daily, For 52 Weeks
Receives: Drug: MT-4666

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimer's disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS)

    Measured: Up to week 56

Secondary outcomes (2)

  1. Change in Mini Mental State Examination (MMSE)

    Measured: baseline to Week 52

  2. Change in Neuropsychiatric Inventory (NPI) total score

    Measured: baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionSep 2015
  4. Study completionOct 2015

Why it stopped: This study was terminated due to the benefit-risk balance of MT-4666.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02327182
Sponsor's protocol ID
P211-05
Status last verified
Nov 2015
First submitted
23 Dec 2014
Last updated
13 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MT-4666 in people with Alzheimer's Disease, run by Tanabe Pharma Corporation at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was terminated due to the benefit-risk balance of MT-4666.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimer's disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: Up to week 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02327182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.

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