E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Participants are males and females age 55 years or greater with AD who have completed either of the feeder studies. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001896 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to assess the safety of solanezumab in AD patients during 24 months of open-label treatment following completion of 18 months of treatment with solanezumab or placebo in a double-blind registration study (LZAM or LZAN) through analysis of adverse events (AEs), vital signs, laboratory evaluations, electrocardiograms (ECGs), and magnetic resonance imaging (MRIs). |
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E.2.2 | Secondary objectives of the trial |
• To test the hypothesis that solanezumab will continue to slow the cognitive and functional decline associated with AD during 24 months of open-label treatment. • To assess the overall clinical benefit of treatment with solanezumab in AD patients during 24 months of open-label treatment, comparing patients randomized to solanezumab with patients randomized to placebo in the feeder studies (LZAM or LZAN). • To provide supporting evidence that solanezumab attenuates the underlying pathologic process in AD, as measured by changes in plasma Aβ levels and by using volumetric magnetic resonance imaging (vMRI) to assess the rate of decline in brain volumes. • In addition, changes in amyloid plaque burden will be determined using positron emission tomography (PET) imaging as an addendum to this study for patients who had previously participated in amyloid imaging procedures in the feeder studies (LZAM or LZAN) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
[1] Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD (McKhann et al. 1984). [2] Has completed Study LZAM or Study LZAN through Visit 23. [3] Must continue to have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week) and will accompany the patient to the office and/or be available by telephone at designated times. Note: The caregiver must be able to communicate with site personnel and be willing to comply with protocol requirements, and in the investigator’s opinion must have adequate literacy to complete the protocol-specified questionnaires. Participants living in an assisted-living facility may be included if regular contact with a caregiver who accompanies the patient is maintained. [4] Must have good venous access, such that intravenous drug delivery and multiple blood draws would be possible. [5] Agrees not to participate in studies of any other investigational compounds for the duration of Study LZAO. |
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E.4 | Principal exclusion criteria |
[6] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [7] Are Eli Lilly and Company (Lilly) employees. [8] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [9] Meets feeder study discontinuation criteria at the last visit of the feeder study (Study LZAO Visit 1). |
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E.5 End points |
E.5.1 | Primary end point(s) |
This is a open label extension study with assessing the safety of solanezumab as the primary objective. As a result there is no primary safety endpoint. The efficacy analysis for the secondary objective will be as follows: The efficacy measures (ADAS-Cog, ADCSADL, CDR-SB, MMSE, NPI, EQ-5D Proxy, and QoL-AD) will be summarized and compared between patients randomized to placebo in the feeder studies and patients randomized to solanezumab in each of the 2 feeder studies as described below. The analysis of each efficacy measure will compare the change from baseline (prior to start of treatment in the feeder study) at each visit during the extension study (where the scale is assessed) between the treatment groups using separate MMRMs for each of the 2 feeder studies. Baseline will be considered as the last visit prior to first infusion in the feeder study. E.6 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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La data dell`ultima visita o l`ultima procedura programmata riportata nella scheda dello studio per l`ultimo paziente attivo in studio. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |