Phase 1
Completed N=86
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
Source: ClinicalTrials.gov NCT00464334 ↗Enrolled (actual)
86
Serious AEs
19.8%
Results posted
Dec 2012
Primary outcomePrimary: Number of Participants Who Experienced at Least One Adverse Event — 4; 11; 7; 8 participants
Summary
The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event |
4; 11; 7; 8; 6; 7 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an Adverse Event |
0; 0; 0; 1; 1; 0 | — |
| PRIMARY Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7 |
363; 542.08; 855; 443; 990; 2208.02 | — |
| PRIMARY Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies |
0.89; 0.76; 0.98; 1.02; 0.15; 2.68 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has mild to moderate Alzheimer Disease
- Women cannot be able to get pregnant
- Patient has a reliable caregiver, who will attend all visits and answer questions about the patient
Exclusion Criteria
- Patient lives in a nursing home or facility
- Patient has another neurological or neurodegenerative disorder
- Patient has a history of stroke
- Patient uses illicit drugs or has a history of drug/alcohol abuse
- Patient has received blood or blood derived products within 6 months
Data sourced from ClinicalTrials.gov (NCT00464334). 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. Informational only — not medical advice.