A comparison study of LMTM and placebo in patients with mild Alzheimer's Disease
- Conditions
- Alzheimer’s DiseaseMedDRA version: 18.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-002847-28-DE
- Lead Sponsor
- TauRx Therapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Diagnosis according to the National Institute on Aging (NIA) and Alzheimer’s Association (AA) criteria of:
• All cause dementia
and
• Probable Alzheimer's disease
2. Clinical Dementia Rating (CDR) total score of 1 (mild) and MMSE
score of 20-26 (inclusive) at Screening
3. Age <90 years at Screening
4. Modified Hachinski ischemic score of =4 at Screening
5. Females must meet one of the following:
• Surgically sterile (hysterectomy, bilateral salpingectomy /
oophorectomy) for at least 6 months minimum
• Have undergone bilateral tubal occlusion / ligation at least 6 months
prior
• Post-menopausal for at least 1 year
• Using adequate contraception (a barrier method [such as condom,
diaphragm or cervical/vault cap] with spermicidal foam, gel, film, cream,
or suppository; intrauterine device [IUD] or system, or oral or longacting
injected or implanted hormonal contraceptives for at least 3
months prior to Baseline; or vasectomized partner [with the appropriate
post-vasectomy documentation of the absence of spermatozoa in the
ejaculate]) or true abstinence (when this is in line with the preferred
and usual lifestyle of the subject); subjects must be competent to use
adequate contraception and to agree to continue to maintain adequate
contraception throughout participation in the study
OR In Italy, have avoided a pregnancy for at least 3 months prior to
Baseline and accept to avoid a pregnancy throughout participation in the
study
6. Subject and/or, in the case of reduced decision-making capacity,
legally acceptable representative(s) consistent with national law is/are
able to read, understand, and provide written informed consent in the
designated language of the study site
• In Germany, subjects must be able to provide their own written
informed consent
7. Has one or more identified adult caregivers who meet the following
criteria:
• Either lives with the subject or sees the subject on average for = 2
hours/day = 3 days/week, or in the investigator's opinion, the extent of
contact is sufficient to provide meaningful assessment of changes in
subject behavior and function over time and provide information on
safety and tolerability
• Is willing to provide written informed consent for his/her own
participation
• Is able to read, understand, and speak the designated language at the
study site
• Agrees to accompany the subject to each study visit
• Is able to verify daily compliance with study drug
8. If currently taking an acetylcholinesterase inhibitor (AChEI), i.e.,
donepezil, galantamine, or rivastigmine, and/or memantine at the time
of Screening:
• The subject must have been taking such medication(s) for = 3 months
• The current dosage regimen and dosage form must be within the
locally approved dose range and must have remained stable for = 6
weeks
• It must be planned that the dosage regimen will remain stable
throughout participation in the study
Subjects not being treated with an AChEI or memantine (for = 6 weeks
before Screening) may also be enrolled if initiation of an AChEI or
memantine is not planned for the time period during which the subject
will be participating in this study
9. Able to comply with the study procedures in the view of the
investigator
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 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for thi
1.Significant CNS disorder other than AD
2.Significant intracranial focal or vascular pathology seen on brain MRI scan within a maximum of 42 days before Baseline that would lead to a diagnosis other than probable AD or that puts the subject at risk of ARIA, including: large confluent white matter hyperintense lesions, other focal brain lesion(s), a single area of superficial siderosis, >4 cerebral microhemorrhages, evidence of a prior macrohemorrhage
3.Clinical evidence or history of any of the following within specified period prior to Baseline:
•Cerebrovascular accident (2 years)
•Transient ischemic attack(6 months)
•Significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment (2 years)
•Other unexplained or recurrent loss of consciousness =15 minutes (2 years)
4.Epilepsy (a single prior seizure is considered acceptable)
5.DSM IV-TR criteria met for any of the following within specified period:
•Major depressive disorder (current)
•Schizophrenia (lifetime)
•Other psychotic disorders, bipolar disorder (within the past 5 years), or substance (including alcohol) related disorders (within the past 2 years)
6.Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging; MR compatible prosthetics, clips, stents, or any other device proven to be compatible will be allowed.
7.Resides in hospital or moderate to high dependency continuous care facility
8.History of swallowing difficulties
9.Pregnant or breastfeeding
10.G6PD deficiency
11.History of significant hematological abnormality or current acute or chronic clinically significant abnormality, including:
•History of hereditary or acquired methemoglobinemia or baseline
measurement of MetHb >2.0%
•History of hemoglobinopathy, myelodysplastic syndrome, hemolytic
anemia, or splenectomy
•Screening hemoglobin value below age/sex appropriate lower limit of
the central laboratory normal range
12.Abnormal serum chemistry laboratory value at Screening. In addition,
subjects with either of the following abnormalities must be excluded:
creatinine clearance <30 mL/min at Screening, TSH above laboratory
normal range (subject may be treated and rescreened after 3 months)
13.Clinically significant cardiovascular disease or abnormal assessments
such as:
•Hospitalization for acute coronary syndrome or symptoms consistent
with angina pectoris, within the 12 months preceding Baseline
•Signs or symptoms of clinical heart failure within the 12 months
preceding Baseline
•Evidence of uncontrolled atrial fibrillation on Screening ECG or history
of atrial fibrillation that is not currently controlled or where the QT
interval cannot be assessed by triplicate ECGs
•QTcF at Screening >460 msec in males or >470 msec in females, or low
or flat T waves making measurement of QT interval unreliable
•Recent history of poorly controlled hypertension, systolic blood
pressure >160 mmHg, or diastolic blood pressure >100 mmHg, at
Screening
•Hypotension: systolic blood pressure <100 mmHg at Screening
•Heart rate <48 bpm or >96 bpm by measurement of vital signs or by
ECG at Screening
14.Preexisting or current signs or symptoms of respiratory failure.
Subjects with previously diagnosed moderate to severe sleep apnea not
adequately controlled should be excluded.
15.Concurrent acute or chronic clinically significant immunologic,
hepatic, or endocr
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