A multicentre, randomised, open label, comparative Phase 4 trial to assess changes in dementia diagnostic category and diagnostic confidence after DaTSCAN imaging in subjects with an uncertain diagnosis of dementia with Lewy bodies (possible DLB) - ND
- Conditions
- Subjects with possible Dementia with Lewy Bodies (DLB) who may or may not also fulfil the criteria for Alzheimers Disease (AD)MedDRA version: 9.1Level: LLTClassification code 10057095
- Registration Number
- EUCTR2010-021474-11-IT
- Lead Sponsor
- GE Healthcare Srl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 174
(1) Male or female 55 years of age or older. (2) Mini-Mental State Examination between 10 and 26. (3) Subjects with Possible DLB as defined by the International Consensus Criteria (dementia +1 core feature or 1 or more suggestive features), who may or may not also fulfil criteria for Alzheimer’s disease (AD). (4) The subject and a legally acceptable representative (e.g., the subject’s carer) are able and willing to comply with study procedures and signed and dated informed consent is obtained from each. (5) The subject and a legally authorised representative are able to co-operate with the protocol and involvement would not adversely affect subject care, in the opinion of the investigator. (6) Women who are surgically sterile (have had documented oophorectomy and/or documented hysterectomy) or are postmenopausal (cessation of menses for more than 1 year) will be allowed to enrol in the study without a pregnancy test at screening.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
(1) Having an established/certain clinical diagnosis of probable DLB or a non-DLB form of dementia. (2) Parkinsonism >1 year prior to onset of dementia. (3) Severe extrapyramidal symptoms (Unified Parkinson’s Disease Rating Scale, Part 3 [UPDRS-III] >30) or Parkinson’s disease dementia. (4) Known/suspected significant vascular pathology with multiple or strategic infarcts or vascular pathology in the striatum/basal ganglia as shown preferably by previous magnetic resonance imaging (MRI) or computed tomography (CT) examination. If an MRI is not clinically feasible, cerebral CT imaging within 6 months prior to baseline is also acceptable. (5) Symptoms suggestive of multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, or Huntington’s disease. (6) Persistent severe mental illness including depression, schizophrenia and schizoaffective illness. (7) Normal pressure hydrocephalus. (8) Use of any concomitant medication that is known or suspected to interact with striatal uptake through direct competition with binding of DaTSCAN to the DAT that could not be discontinued for at least 5 half-lives if the subject were to be randomized to the DaTSCAN group (these include amphetamine, benztropine, bupropion, cocaine, mazindol, methylphenidate, phentermine and sertraline). (9) Presence of moderate to severe renal or hepatic impairment. (10) Occupational exposure to radiation equal to or above 15 mSv per year. (11) History of abuse or current abuse of drugs. (12) History of alcohol abuse where period of abstinence is less than 3 years. (13) Hypersensitivity to DaTSCAN or any of its ingredients. (14) Previous inclusion in this study. (15) Female subjects who are pregnant or breast-feeding or planning a pregnancy during the course of this study or within 3 cycles of completing the study. Women of childbearing potential, have to provide a negative beta human chorionic gonadotropin (b-HCG) pregnancy test (by urine dipstick method) at screening and also prior to investigational medicinal product (IMP) administration. (16) Participation in a clinical study involving an unlicensed pharmaceutical product within 30 days prior to screening, and/or an unlicensed/licensed radiopharmaceutical within 5 radioactive half-lives prior to screening. (17) The subject has a life threatening disease state with a life expectancy of less than 1 year or history of significant medical disease, trauma, or surgical intervention that in the judgement of the investigators makes the subject unsuitable for the study. (18) The subject has already had DaTSCAN SPECT imaging or any other similar functional imaging test of the pre-synaptic and/or post-synaptic dopaminergic system (e.g. 18FDOPA PET, 123I iodobenzamide).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the impact of DaTSCAN imaging on diagnostic category in subjects with an uncertain diagnosis of DLB (possible DLB).;Secondary Objective: To demonstrate that the use of DaTSCAN improves confidence in diagnosis in these subjects.;Primary end point(s): Change in a clinical diagnostic category at week 8 (V2) compared to baseline (V1)
- Secondary Outcome Measures
Name Time Method