Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

This study has been completed.

Sponsor:

Collaborator:

Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00479557

First received: May 24, 2007

Last updated: November 30, 2015

Last verified: November 2015

History of Changes

Results First Received: May 6, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Alzheimer Disease
Interventions:	Biological: ACC-001 + QS-21 Biological: ACC-001 Biological: QS-21 Drug: Placebo: Phosphate buffered saline

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
Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the 3134K1-200-EU (B2571004) study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol 3134K1-2203-EU (B2571007).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Basic Results disclose pooled data from studies NCT00479557 and NCT00498602.

Reporting Groups

	Description
ACC 3 µg+QS-21	Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 10 µg+QS-21	Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 30 µg+QS-21	Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 10 µg	Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 30 µg	Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
QS-21 Alone	Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Phosphate Buffered Saline	Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.

Participant Flow: Overall Study

	ACC 3 µg+QS-21	ACC 10 µg+QS-21	ACC 30 µg+QS-21	ACC 10 µg	ACC 30 µg	QS-21 Alone	Phosphate Buffered Saline
STARTED	36	61	40	35	12	44	17
Treated	36	60 ^[1]	40	35	12	44	17
COMPLETED	26	51	32	30	8	31	15
NOT COMPLETED	10	10	8	5	4	13	2
Death	0	0	0	0	0	1	0
Lack of Efficacy	1	0	0	0	0	0	0
Lost to Follow-up	0	2	0	2	0	0	0
Adverse Event (AE) related to Study Drug	1	0	3	2	0	1	0
AE not related to Study Drug	1	3	0	0	2	2	1
Caregiver Request	2	2	2	0	1	2	0
Investigator Request	0	0	1	0	0	0	0
Subject Request	3	0	1	1	1	4	1
Not specified	2	3	1	0	0	3	0

^[1]	One participant discontinued due to an AE, with an outcome of death.

Baseline Characteristics

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Outcome Measures

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1. Primary:

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [ Time Frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose. ]

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2. Secondary:

Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]

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3. Secondary:

GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]

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4. Secondary:

Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable) [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00479557 History of Changes
Other Study ID Numbers:	3134K1-200 B2571004 ( Other Identifier: Alias Study Number ) 2006-002061-39 ( EudraCT Number )
Study First Received:	May 24, 2007
Results First Received:	May 6, 2014
Last Updated:	November 30, 2015

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