A study to evaluate the efficacy and safety of T 817MA in patients with mild cognitive impairment due to Alzheimer’s Disease or mild Alzheimer’s Disease.Patients to be randomly allocated to either placebo or investigational drug; assignment will be unknown to patients and doctor.
- Conditions
- Mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease.MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852MedDRA version: 20.0 Level: LLT Classification code 10009846 Term: Cognitive impairment System Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-003567-66-ES
- Lead Sponsor
- FUJIFILM Toyama Chemical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 200
Patients must meet all of the following inclusion criteria to be eligible for enrolment:
1.Male or female, age 50 to 80 inclusive at screening.
2.Diagnosis by the investigator of a clinical syndrome of cognitive impairment consistent with either MCI due to AD or mild AD per NIA-AA diagnostic criteria (Jack et al., 2018), with MMSE 24 to 30 (inclusive).
3.CSF results at screening consistent with the presence of Aß and p-tau181 abnormality (=1000 pg/ml for Aß, =19 pg/ml for p-tau181).
4.A brain MRI not-inconsistent with the clinical diagnosis of MCI due to AD or mild AD
5.Recieving an AChE inhibitor (donepezil, galantamine or rivastigmine) at a stable dose for more than 3 months prior to randomization, or not receiving any AChE inhibitors.
6.Weight of = 100 kg (220 pounds) at Screening
7.Ability (patients and their study partners) to read, speak and understand local language to ensure compliance with cognitive testing and study visit procedures
8.Living in the community (includes assisted living facilities, but excludes long-term care nursing facilities)
9.Ambulatory, or able to walk with an assistive device, such as a cane or walker
10.Female patients must be post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) for at least 6 months prior to Screening. Otherwise, female patients must have male sex partners use condoms, or the male partner must be confirmed azoospermic after vasectomy.
11.A study partner who has regular contact with the patient for at least 10 hours per week and is able to oversee the patient’s compliance with study medication and participate in the patient’s clinical assessment
12.Provision of informed consent from the patient and the study partner
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Patients meeting any of the following criteria must not be included in the study:
1.Has had an MRI of the brain within the previous 2 years that showed pathology that would be inconsistent with a diagnosis of AD
2.Use of prohibited medications, including memantine.
3.Has any contraindications for MRI including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI
4.Has any contraindications to lumbar puncture
5.Psychiatric disorder such as schizophrenia or dementia not of the Alzheimer’s type according to the criteria of DSM-5
6.Other neurodegenerative diseases, including Parkinson’s disease and Huntington’s disease, or cerebral tumor
7.Dementia other than AD
8.History of untreated thyroid disorder, Type I diabetes, and insulin-dependent or uncontrolled Type II diabetes, as determined by the investigator (except non-insulin-controlled Type II diabetes, whose HbA1c value must be below 8.0 %)
9.History of a seizure disorder and stroke, unless >5 years ago
10.Current or systemic disorder that the investigator deems makes them ineligible
11.History of alcohol abuse or dependence or drug abuse in the past 5 years
12.Uncorrected impairment of vision or hearing that would preclude the patient from taking tests or patients lacking the ability to communicate
13.Clinically significant abnormal laboratory values in the opinion of the investigator
14.Clinically significant hepatic or renal impairment, or significant B12 deficiency (i.e., no macrocytosis) in the opinion of the investigator
15.Severe heart disease (history of myocardial infarction, congestive heart disease, history of unstable angina pectoris, clinically significant ECG abnormality) within 6 months prior to screening. Patients with arterial thrombosis will not be excluded if they are stable for at least 6 months prior to Screening
16.Cancer or a malignant tumor within the past 3 years, except patients who underwent potentially curative therapy with no evidence of recurrence. (Patients with stable untreated prostate cancer or skin cancers are not excluded.)
17.Participation in another clinical trial for an investigational agent and having taken at least one dose of study medication, unless confirmed as having been on placebo, within 12 weeks prior to screening. (The end of a previous investigational trial is defined as the date of the last dose of an investigational agent.)
18.Having received an active Aß vaccine in another clinical trial
19.Participation in a previous clinical trial with T 817MA
20.Patients whom the investigator deems to be otherwise ineligible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method