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CompletedPhase 1Results posted

A Study of V950 in People With Alzheimer Disease (V950-001 AM7)

A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIX™ in Patients With Alzheimer Disease

Asset

V950

Listed sites

0

Recruiting sites

-

Enrollment

86

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•Study partner/caregiver required

Primary endpoints

•At Least One Adverse Event•Number of Participants Who Discontinued Study Drug Due to an Adverse Event•Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies

Identifiers

Registered as

Secondary ID2007_518Merck Registration ID
NCT IDNCT00464334
Org study IDV950-001

Timeline

Milestones

Study start2007-03 (month precision)
Study first posted2007-04-23estimated
Primary completion2012-01actual (month precision)
Study completion2012-01actual (month precision)
Results first posted2012-12-18estimated
Last update posted2015-09-25estimated

Assets

Drug assets

V950

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
6
Amyloid biomarkers
2

Amyloid biomarkers

2 endpoints
Primary/protocol endpoint

Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7

Time frame:Month 7

descriptive

Primary/registry result

Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7

Time frame:Month 7

descriptive

Posted result

GroupValue (geometric_mean), ng/mLReported bounds
Placebo to V950/IMX 0 mcgn=4 Participants363-161 - 729
Placebo to V950/IMX 16 mcgn=4 Participants542.08-310.16 - 818.02
V950 0.5 mcg/IMX 0 mcgn=8 Participants855-575 - 1275
V950 0.5 mcg/IMX 16 mcgn=7 Participants443-345 - 560
V950 0.5 mcg/IMX 47 mcgn=1 Participants990-990 - 990
V950 0.5 mcg/IMX 94 mcgn=6 Participants2208.02-628.53 - 12105
V950 5 mcg/IMX 0 mcgn=9 Participants725-378 - 1385
V950 5 mcg/IMX 16 mcgn=1 Participants3835-3835 - 3835
V950 5 mcg/IMX 47 mcgn=6 Participants1277.38-604.83 - 2453.4
V950 50 mcg/IMX 16 mcgn=5 Participants935.55-447.14 - 1728.0

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Number of Participants Who Experienced at Least One Adverse Event

Time frame:Up to 4 years after first dose of vaccine

change from baseline, event

Primary/protocol endpoint

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Time frame:Up to 6 months after first dose of vaccine

change from baseline, event

Primary/protocol endpoint

Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies

Time frame:Baseline and Month 7

change from baseline, event

Primary/registry result

Number of Participants Who Experienced at Least One Adverse Event

Time frame:Up to 4 years after first dose of vaccine

change from baseline, event

Posted result

GroupValue (number), participantsReported bounds
Placebo to V950/ IMX 0 mcgn=5 Participants4-
Placebo to V950/ IMX 16 mcgn=13 Participants11-
V950 0.5 mcg / IMX 0 mcgn=8 Participants7-
V950 0.5 mcg / IMX 16 mcgn=8 Participants8-
V950 0.5 mcg / IMX 47 mcgn=7 Participants6-
V950 0.5 mcg / IMX 94 mcgn=7 Participants7-
V950 5 mcg / IMX 0 mcgn=9 Participants9-
V950 5 mcg / IMX 16 mcgn=8 Participants8-
V950 5 mcg / IMX 47 mcgn=8 Participants8-
V950 50 mcg / IMX 0 mcgn=5 Participants5-
V950 50 mcg / IMX 16 mcgn=8 Participants8-
Primary/registry result

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Time frame:Up to 6 months after first dose of vaccine

change from baseline, event

Posted result

GroupValue (number), participantsReported bounds
Placebo to V950/ IMX 0 mcgn=5 Participants0-
Placebo to V950/ IMX 16 mcgn=13 Participants0-
V950 0.5 mcg / IMX 0 mcgn=8 Participants0-
V950 0.5 mcg / IMX 16 mcgn=8 Participants1-
V950 0.5 mcg / IMX 47 mcgn=7 Participants1-
V950 0.5 mcg / IMX 94 mcgn=7 Participants0-
V950 5 mcg / IMX 0 mcgn=9 Participants1-
V950 5 mcg / IMX 16 mcgn=8 Participants0-
V950 5 mcg / IMX 47 mcgn=8 Participants3-
V950 50 mcg / IMX 0 mcgn=5 Participants1-
V950 50 mcg / IMX 16 mcgn=8 Participants2-
Primary/registry result

Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies

Time frame:Baseline and Month 7

change from baseline, event

Posted result

GroupValue (geometric_mean), fold changeReported bounds
Placebo to V950/ IMX 0 mcgn=4 Participants0.89-0.70 - 1.16
Placebo to V950/ IMX 16 mcgn=4 Participants0.76-0.49 - 1.06
V950 0.5 mcg / IMX 0 mcgn=8 Participants0.98-0.79 - 1.17
V950 0.5 mcg / IMX 16 mcgn=7 Participants1.02-0.82 - 1.27
V950 0.5 mcg / IMX 47 mcgn=1 Participants0.15-0.15 - 0.15
V950 0.5 mcg / IMX 94 mcgn=6 Participants2.68-1.03 - 8.66
V950 5 mcg / IMX 0 mcgn=9 Participants0.74-0.18 - 1.80
V950 5 mcg / IMX 16 mcgn=1 Participants2.27-2.27 - 2.27
V950 5 mcg / IMX 47 mcgn=5 Participants1.38-0.84 - 2.78
V950 50 mcg / IMX 16 mcgn=5 Participants1.84-1.29 - 2.67

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.