Study of F03 in Patients with Mild Cognitive Impairment due to Alzheimer's Disease
- Conditions
- Mild Cognitive Impairment due to Alzheimer's DiseaseNeurological - Alzheimer's disease
- Registration Number
- ACTRN12613000967785
- Lead Sponsor
- Southern Star Research Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 36
Be male or a postmenopausal female and be > or = 50 to < or = 75 years of age at screening
- Have a diagnosis of Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease (AD) consistent with the criteria established by Petersen et al (1999) and the 2011 recommendations from the National Institute of Aging-Alzheimer’s Association workgroups within six (6) months of the screening visit based on:
a. A memory complaint verified by an informant (e.g. study partner)
b. Mini Mental State Examination score between 24 and 30 (inclusive)
c. A Clinical Dementia Rating score of at least 0.5 (Memory Box score of 0.5 or 1 and no other Box score greater than 1)
d. Impairment in one or more memory cognitive domains (greater than would be expected for the subject’s age and educational background) as demonstrated by impaired performance in one or both of the following:
a. A total learning raw or delayed free recall (five learning trials) score of a 16- item California Verbal Learning Test-Second Edition (CVLT-II) lower than 1.5 standard deviations (SD) of the corresponding age- and education- adjusted mean score in healthy aged people (Delis et al., 2000);
b. Impaired delayed recall score on one paragraph from the Wechsler Memory Scale Revised - Logical Memory II (Weschler, 1997), below an education- adjusted norm defined as follows:
a. < or = 8, for 16 or more years of education
b. < or = 4, for 8-15 years of education
c. < or = 2, for 0-7 years of education
e. General cognition and functional performance sufficiently preserved (activities of daily living (ADL) score of 6/6 or instrumental activities of daily living (IADL) score > or = 15/17) so that a diagnosis of AD cannot be made, as assessed by the Investigator
f. Absence of dementia, as verified by clinical judgment that the patient(s) does not meet the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association criteria
- Have a 3T MRI showing volumetric loss in the entorrhinal cortex and hippocampus and consistent with a diagnosis of MCI due to AD
- Have a reliable study partner (informant) who agrees to monitor administration of study drug, who can accompany the subject to all study visits and who is able to provide an independent evaluation of function
- Be willing and able to undergo all test procedures including two (2) lumbar punctures and ApoE and CYP2D6 assessments
- Voluntarily sign and date an informed consent agreement approved by the Human Research Ethics Committee (HREC).
- Have received prescribed medical therapies for MCI due to AD within the three (3) months prior to the first dose of study drug or plan to use any of these medical therapies at any time during the study
- Have a history of angina, congestive heart failure, cardiac arrhythmias or any other cardiac disease requiring ongoing treatment
- Have a clinically significant ECG abnormality in the opinion of the investigator, have a history of cardiac QTc interval prolongation or are taking any medications known to prolong the QTc interval unless these can be stopped for at least five (5) half-lives prior to the first dose of study drug
- Have any significant neurologic disease other than MCI due to AD (including stroke, Parkinson's disease, seizure disorder, history of significant head trauma followed by persistent neurologic deficits, known structural brain abnormalities, major depression or bipolar disorder, schizophrenia), and specifically:
i. Have significant cerebral vascular disease, as indicated by a modified Hachinski score of greater than 4
ii. Have depression, as indicated by a Hamilton Depression Rating Scale score of more than 12
- Have a history of alcohol abuse, substance abuse or dependence within two (2) years of study screening
- Have psychotic features, agitation or behavioral problems within three (3) months of study screening
- Have any of the following:
a. uncontrolled hypertension, as determined by the investigator;
b. insulin-dependent diabetes mellitus;
c. clinically significant abnormalities of renal function (serum creatinine >2 times upper limit of normal) or hepatic function (AST, ALT >2 times upper limit of normal);
d. known active hepatitis B or C;
e. known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
- Received or have a requirement during the study for any of the following:
a. systemic corticosteroids within two (2) months prior to screening;
b. medications with significant cholinergic or anticholinergic side effects (e.g. tacrine, donepezil, pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within four (4) weeks prior to screening;
c. anticonvulsants (e.g. phenytoin, phenobarbital, carbamazepine) within two (2) months prior to screening;
d. anticoagulant therapy e.g. warfarin within four (4) weeks prior to screening;
e. narcotic analgesics within one (1) week prior to screening (excludes over-the-counter formulations such as paracetamol/codeine);
f. antipsychotics, psychostimulants, antidepressants;
g. 5-HT3 receptor antagonists within two (2) weeks prior to screening;
h. Immunotherapy e.g. monoclonal antibodies within three (3 months) prior to screening
- Are taking medications that are known to inhibit CYP2D6
- Are actively using or have used within 12 months prior to screening tobacco- or nicotine-containing products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method