Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

This study has been completed.

Sponsor:

Collaborator:

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01227564

First received: October 22, 2010

Last updated: January 28, 2016

Last verified: January 2016

History of Changes

Results First Received: February 9, 2015

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's Disease
Interventions:	Biological: ACC-001 3 μg/ QS-21 50 μg Biological: ACC-001 10 μg/ QS-21 50 μg Other: Placebo- Phosphate buffered saline (PBS)

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
Twenty study centers in the United States of America participated. One of these did not enroll any participants.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants, who were found eligible, were randomized to 1 of 3 groups in a 1:1:1 ratio between ACC-001 3 μg+QS-21, or ACC-001 10 μg+QS-21, or placebo (which was administrated as phosphate buffered saline [PBS]). The study randomization was stratified based on apolipoprotein E (Apo E) genotype (E4 carrier or non-carrier).

Reporting Groups

	Description
ACC 3 μg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
ACC 10 μg+QS-21	Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
Placebo	Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.

Participant Flow: Overall Study

	ACC 3 μg+QS-21	ACC 10 μg+QS-21	Placebo
STARTED	22	20	21
Treated	22	20	21
Completed Treatment	21 ^[1]	18 ^[2]	17 ^[3]
COMPLETED	18 ^[4]	18 ^[4]	15 ^[4]
NOT COMPLETED	4	2	6
No Longer Willing to Participate	4	2	5
Participant moved to another town	0	0	1

^[1]	1 participant discontinued treatment due to an adverse event (AE).
^[2]	2 participants discontinued treatment due to no longer willing to participate in study.
^[3]	1 participant stopped treatment due to lack of efficacy, 3 due to no longer willing to participate.
^[4]	Completed study

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
ACC 3 μg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
ACC 10 μg+QS-21	Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
Placebo	Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
Total	Total of all reporting groups

Baseline Measures

ACC 3 μg+QS-21

ACC 10 μg+QS-21

Placebo

Total

Overall Participants Analyzed
[Units: Participants]

Age
[Units: Years]
Mean (Standard Deviation)

66.8 (7.31)

68.5 (7.02)

69.6 (6.82)

68.3 (7.04)

Gender
[Units: Participants]

Female

Male

MMSE Score ^[1]
[Units: Score]
Mean (Standard Deviation)

27.3 (1.64)

27.7 (1.63)

28.0 (1.47)

27.6 (1.58)

^[1]

The MMSE is a brief, structured examination of cognitive function consisting of the 11 item: Orientation-What, Orientation-Where, Registration-Objects, Attention and Calculation, Recall, Language-Naming, Language-Repetition, Language-Comprehension, Language-Reading, Language-Writing, and Language- Drawing. MMSE total score was the sum of the 11 item scores and it ranges from 0 to 30 with higher score indicating greater cognitive functioning. If any individual item is missing, then the MMSE total score is set to missing.

Outcome Measures

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1. Primary:

Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs) [ Time Frame: 104 weeks ]

Show Outcome Measure 1

2. Other Pre-specified:

Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40 [ Time Frame: Week 80 or Week 104 ]

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3. Other Pre-specified:

Change From Baseline in CSF Aβ x-42 [ Time Frame: Week 80 or Week 104 ]

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4. Other Pre-specified:

Change From Baseline in CSF p-Tau [ Time Frame: Week 80 or Week 104 ]

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5. Other Pre-specified:

Change From Baseline in CSF Total Tau [ Time Frame: Week 80 or Week 104 ]

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6. Other Pre-specified:

Change From Baseline in Plasma Aβ x-40 [ Time Frame: 104 weeks ]

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7. Other Pre-specified:

Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI) [ Time Frame: 104 weeks ]

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8. Other Pre-specified:

Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI) [ Time Frame: 104 weeks ]

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9. Other Pre-specified:

Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total [ Time Frame: 104 weeks ]

Show Outcome Measure 9

10. Other Pre-specified:

Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left [ Time Frame: 104 weeks ]

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11. Other Pre-specified:

Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right [ Time Frame: 104 weeks ]

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12. Other Pre-specified:

Change From Baseline in Neuropsychological Test Battery (NTB) [ Time Frame: 104 weeks ]

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13. Other Pre-specified:

Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score [ Time Frame: 104 weeks ]

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14. Other Pre-specified:

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) [ Time Frame: 104 weeks ]

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15. Other Pre-specified:

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score [ Time Frame: 104 weeks ]

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16. Other Pre-specified:

Change From Baseline in NPI Distress Score (NPI-D) [ Time Frame: 104 weeks ]

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17. Other Pre-specified:

Change From Baseline in Mini Mental State Examination (MMSE) Total Score [ Time Frame: 104 weeks ]

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18. Other Pre-specified:

Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score [ Time Frame: 104 weeks ]

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19. Other Pre-specified:

Change From Baseline in Dependence Scale (DS) Score [ Time Frame: 104 weeks ]

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20. Other Pre-specified:

Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver [ Time Frame: 104 weeks ]

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21. Other Pre-specified:

Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers [ Time Frame: 104 weeks ]

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22. Other Pre-specified:

Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time [ Time Frame: 104 weeks ]

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23. Other Pre-specified:

Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers [ Time Frame: 104 weeks ]

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24. Other Pre-specified:

Geometric Mean Anti-Aβ IgM ELISA Titers [ Time Frame: 104 weeks ]

Show Outcome Measure 24

25. Other Pre-specified:

Change From Baseline in Perceived Deficits Questionnaire (PDQ) – Subject – Attention/Concentration Domain Score [ Time Frame: 104 weeks ]

Show Outcome Measure 25

26. Other Pre-specified:

Change From Baseline in PDQ – Subject – Retrospective Memory Domain Score [ Time Frame: 104 weeks ]

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27. Other Pre-specified:

Change From Baseline in PDQ – Subject – Prospective Memory Domain Score [ Time Frame: 104 weeks ]

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28. Other Pre-specified:

Change From Baseline in PDQ – Subject – Planning/Organization Domain Score [ Time Frame: 104 weeks ]

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29. Other Pre-specified:

Change From Baseline in PDQ – Subject – Total Score [ Time Frame: 104 weeks ]

Show Outcome Measure 29

30. Other Pre-specified:

Change From Baseline in PDQ-R – Relative – Attention/Concentration Domain Score [ Time Frame: 104 weeks ]

Show Outcome Measure 30

31. Other Pre-specified:

Change From Baseline in PDQ-R – Relative – Retrospective Memory Domain Score [ Time Frame: 104 weeks ]

Show Outcome Measure 31

32. Other Pre-specified:

Change From Baseline in PDQ-R – Relative – Prospective Memory Domain Score [ Time Frame: 104 weeks ]

Show Outcome Measure 32

33. Other Pre-specified:

Change From Baseline in PDQ-R – Relative – Planning/Organization Domain Score [ Time Frame: 104 weeks ]

Show Outcome Measure 33

34. Other Pre-specified:

Change From Baseline in PDQ-R – Relative – Total Score [ Time Frame: 104 weeks ]

Show Outcome Measure 34

35. Other Pre-specified:

Alzheimer’s Disease Medication Administration Concerns Questionnaire (AD MACQ) [ Time Frame: 104 weeks ]

Show Outcome Measure 35

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
In 2013 Pfizer and Janssen Alzheimer Immunotherapy Alliance made the decision that ACC-001 would not be further developed in mild to moderate AD.

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

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01227564 History of Changes
Other Study ID Numbers:	B2571010 3134K1-2208 ( Other Identifier: Alias Study Number )
Study First Received:	October 22, 2010
Results First Received:	February 9, 2015
Last Updated:	January 28, 2016

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