A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia
- Conditions
- behavioral variant Frontotemporal Dementia (bvFTD)MedDRA version: 17.1Level: PTClassification code 10068968Term: Frontotemporal dementiaSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-005529-34-NL
- Lead Sponsor
- TauRx Therapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1. Diagnosis of probable bvFTD according to the International Consensus Criteria for bvFTD
2. Centrally rated frontotemporal atrophy score of 2 or greater, taken as the maximum of right or left frontal or anterior temporal lobes on brain MRI of sufficient quality obtained at Screening or within a maximum of 42 days before Baseline, irrespective of pre-existing structural or functional imaging evidence supporting a diagnosis of bvFTD
3. MMSE =20 at the Screening visit
4. Age <80 years at the Screening visit
5. Modified Hachinski ischemic score of =4 at the Screening visit
6. 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
long-acting 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
7. 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
8. Has one or more identified adult caregivers who meets 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
9. If currently taking an 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
10. 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 90
F.1.3 Elderly (>=
1.Significant CNS disorder other than bvFTD
2.Other significant intracranial pathology seen on brain MRI scan that would lead to a diagnosis other than probable bvFTD or puts the subject at risk of Amyloid Related Imaging Abnormalities including:large confluent white matter hyperintense lesions, other focal brain lesion(s),single area of superficial siderosis,>4 cerebral microhemorrhages,evidence of a prior macrohemorrhage.
3.Biomarker evidence of underlying AD pathology as etiology of dementia
4.Expressive language deficits such the subject is too severely impaired to allow testing at Baseline
5.Meets research criteria for Amyotrophic Lateral Sclerosis or motor;evidence of mild motor neuron disease on examination is allowed if not expected to interfere with subject's completion of study but prominent bulbar symptoms would be exclusionary
6.Meets diagnostic criteria for probable bvFTD but has a proven mutation producing non-tau, non-TDP-43 pathology
7.Clinical evidence or history of:
·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)
8.Epilepsy (a single prior seizure is considered acceptable)
9.Rapid eye movement sleep behavior disorder
10.DSM IV-TR criteria met for the following within specified period:
·Major depressive disorder(current)
·Schizophrenia(lifetime)
·Other psychotic disorders, bipolar disorder (within the past 5 years),or substance related disorders(within past 2 years)
11.Metal implants in the head (except dental),pacemaker, any other non-removable items that are contraindications to MR imaging; any device proven to be MR compatible will be allowed.
12.Resides in hospital or moderate to high dependency continuous care facility
13.History of swallowing difficulties
14.Pregnant or breastfeeding
15.G6PD deficiency
16.History of significant hematological abnormality or current acute or chronic clinically significant abnormality, including:
·Hereditary or acquired methemoglobinemia or Baseline measurement of MetHb >2.0%
·Hemoglobinopathy, myelodysplastic syndrome,hemolytic anemia,or splenectomy
·Screening value below normal range for hemoglobin and vitamin B12 or folate
17.Abnormal serum chemistry laboratory value at Screening clinically relevant. In addition, subjects with the following abnormalities must be excluded:
·Creatinine clearance <50 mL/min at Screening
·Thyroid stimulating hormone above laboratory normal range
18.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
·Hypotension
·Heart rate <48 bpm or >96 bpm by measurement of vital signs or by ECG at Screening
19.Preexisting or current signs or symptoms of respiratory failure.
Subjects with previously diagnosed moderate to severe sleep apnea not
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