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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00464334

First received: April 20, 2007

Last updated: November 19, 2012

Last verified: November 2012

History of Changes

Results First Received: November 19, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Diagnostic
Condition:	Alzheimer Disease
Interventions:	Biological: V950 Biological: ISCOMATRIX™ Biological: Placebo to V950

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 51 sites in Europe, South America and the United States. The primary treatment period was from June 2007 to August 2010, with follow up through January 2012.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo to V950/IMX 0 Mcg	Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
Placebo to V950/IMX 16 Mcg	Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 Mcg/IMX 0 Mcg	Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 Mcg/IMX 16 Mcg	Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 Mcg/IMX 47 Mcg	Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 Mcg/IMX 94 Mcg	Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 Mcg/IMX 0 Mcg	Participants receive V950 5 mcg/IMX 0 mcg
V950 5 Mcg/IMX 16 Mcg	Participants receive V950 5 mcg/IMX 16 mcg
V950 5 Mcg/IMX 47 Mcg	Participants receive V950 5 mcg/IMX 47 mcg
V950 50 Mcg/IMX 0 Mcg	Participants receive V950 50 mcg/IMX 0 mcg
V950 50 Mcg/IMX 16 Mcg	Participants receive V950 50 mcg/IMX 16 mcg

Participant Flow: Overall Study

	Placebo to V950/IMX 0 Mcg	Placebo to V950/IMX 16 Mcg	V950 0.5 Mcg/IMX 0 Mcg	V950 0.5 Mcg/IMX 16 Mcg	V950 0.5 Mcg/IMX 47 Mcg	V950 0.5 Mcg/IMX 94 Mcg	V950 5 Mcg/IMX 0 Mcg	V950 5 Mcg/IMX 16 Mcg	V950 5 Mcg/IMX 47 Mcg	V950 50 Mcg/IMX 0 Mcg	V950 50 Mcg/IMX 16 Mcg
STARTED	5	13	8	8	7	7	9	8	8	5	8
COMPLETED	4	5	3	4	3	3	6	7	2	4	4
NOT COMPLETED	1	8	5	4	4	4	3	1	6	1	4
Adverse Event	0	0	0	1	1	1	0	0	2	1	2
Lack of Efficacy	0	1	0	0	0	0	0	0	0	0	0
Lost to Follow-up	0	0	1	0	1	0	1	0	0	0	2
Progressive Disease	0	0	0	0	0	1	0	0	1	0	0
Study Terminated by Sponsor	0	0	0	1	0	0	0	0	0	0	0
Withdrawal by Subject	1	7	4	2	2	2	2	1	3	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo to V950/IMX 0 Mcg	Participants receive Placebo to V950/IMX 0 mcg
Placebo to V950/IMX 16 Mcg	Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 Mcg/IMX 0 Mcg	Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 Mcg/IMX 16 Mcg	Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 Mcg/IMX 47 Mcg	Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 Mcg/IMX 94 Mcg	Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 Mcg/IMX 0 Mcg	Participants receive V950 5 mcg/IMX 0 mcg
V950 5 Mcg/IMX 16 Mcg	Participants receive V950 5 mcg/IMX 16 mcg
V950 5 Mcg/IMX 47 Mcg	Participants receive V950 5 mcg/IMX 47 mcg
V950 50 Mcg/IMX 0 Mcg	Participants receive V950 50 mcg/IMX 0 mcg
V950 50 Mcg/IMX 16 Mcg	Participants receive V950 50 mcg/IMX 16 mcg
Total	Total of all reporting groups

Baseline Measures

	Placebo to V950/IMX 0 Mcg	Placebo to V950/IMX 16 Mcg	V950 0.5 Mcg/IMX 0 Mcg	V950 0.5 Mcg/IMX 16 Mcg	V950 0.5 Mcg/IMX 47 Mcg	V950 0.5 Mcg/IMX 94 Mcg	V950 5 Mcg/IMX 0 Mcg	V950 5 Mcg/IMX 16 Mcg	V950 5 Mcg/IMX 47 Mcg	V950 50 Mcg/IMX 0 Mcg	V950 50 Mcg/IMX 16 Mcg	Total
Number of Participants [units: participants]	5	13	8	8	7	7	9	8	8	5	8	86
Age [units: years] Mean ± Standard Deviation	73.6 ± 10.69	70.7 ± 9.6	76.9 ± 4.39	73.6 ± 8.07	76.1 ± 8.01	73.4 ± 10.89	72.6 ± 9.26	72.5 ± 10.10	81.5 ± 5.48	70.6 ± 8.38	75.5 ± 10.04	74.2 ± 8.85
Gender [units: participants]
Female	3	7	3	5	5	6	4	5	1	3	3	45
Male	2	6	5	3	2	1	5	3	7	2	5	41

Outcome Measures

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1. Primary:

Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 4 years after first dose of vaccine ]

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2. Primary:

Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 6 months after first dose of vaccine ]

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3. Primary:

Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7 [ Time Frame: Month 7 ]

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4. Primary:

Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies [ Time Frame: Baseline and Month 7 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00464334 History of Changes
Other Study ID Numbers:	V950-001, 2007_518
Study First Received:	April 20, 2007
Results First Received:	November 19, 2012
Last Updated:	November 19, 2012
Health Authority:	United States: Food and Drug Administration

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