Phase 1
N=56
A Non-drug Methods Study in Participants With Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01459016 ↗Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Feb 2017
Primary outcome: Primary: Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI) — 6.349; 11.663; 2.016; 4.196 milliliters (mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PET scan using florbetapir (Other); MRI Scan (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI) |
6.349; 11.663; 2.016; 4.196 | — |
| PRIMARY Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg) |
-1.693; -3.057 | — |
| PRIMARY Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI) |
0.017; 0.031; -0.012; -0.025; -0.029; -0.031 | — |
| PRIMARY Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA) |
-0.024; -0.021; -0.016; 0.009; -0.043; -0.020 | — |
| PRIMARY Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD) |
0.201; 0.761; 0.663; -0.519; 0.410; 0.164 | — |
| SECONDARY Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir |
1.581 | — |
| SECONDARY Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T) |
4 | — |
| SECONDARY Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T |
16; 12; 9 | — |
| SECONDARY Change From Baseline in the Mini Mental State Examination (MMSE) Total Score |
-1.2; -1.8 | — |
| SECONDARY Change From Baseline in the Alzheimer's Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score |
0.1; 0.7 | — |
| SECONDARY Change From Baseline in the Clinical Dementia Rating (CDR) Total Score |
0.1; 0.1 | — |
Summary
This study will investigate the volume, function and composition of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning technology in participants with memory complaints or early signs of Alzheimer's pathology.
Eligibility Criteria
Inclusion Criteria
- Present with prodromal Alzheimer's Disease (AD) or mild AD based on the disease diagnostic criteria
- Are men or post-menopausal women, at least 55 years of age. Post-menopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years
- Have a caretaker/study informant who provides a separate written informed consent to participate. If a caretaker/study informant cannot continue, one replacement is allowed
- Gradual and progressive change in memory function reported by participants or informants over more than 6 months
- Objective evidence of significantly impaired episodic memory characteristic of hippocampal dysfunction on testing: Free and Cued Selective Reminding Test (FCSRT): less than or equal to (≤) 16 for free recall or ≤ 40 for total recall. Protocol amendment: FCSRT ≤ 24 for free recall or ≤ 44 for total recall
- Clinical Dementia Rating (CDR) equals 0.5 or 1, Memory box score greater than or equal to 0.5
- Mini Mental Scale Examination (MMSE) 20-30. Protocol amendment: MMSE 23-30, inclusive
- Positive florbetapir F 18 scan
- Participants must meet all of the Disease Diagnostic Criteria to be considered for enrollment
Exclusion Criteria
- Diagnosis or history of other possible etiology of dementia, including but not limited to other neurodegenerative disorders
- Frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's Disease or concomitant Parkinson's disease, progressive supranuclear palsy (PSNP) or other movement disorder
- Has B12 2 seconds, second or third degree heart block, QTc >450 msec for males or QTc >470 for females
- Treatment with an investigational small molecule within 1 year preceding the first study period, or participation in a trial with active or passive immunization against amyloid if participant was assigned to the active treatment arm
- Fulfillment of any contraindications to a 3T magnetic resonance imaging (MRI) scan (for example, subjects with non-removable ferromagnetic implants (such as cardiac pacemaker), aneurysm clips or other foreign bodies, or subjects with claustrophobic symptoms that would contraindicate an MRI scan)
- Sensitivity to florbetapir F 18
- Are not capable of swallowing whole oral medications
- Abnormal thyroid function
- Thyroid stimulating hormone (TSH) values are outside of the normal range 0.3-5.6 mIU/L. (NOTE: Participants with stable treatment of hypothyroidism and with normal value of TSH will be allowed to enter the study)
Data sourced from ClinicalTrials.gov (NCT01459016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.