Study in patients suffering of Alzheimer disease in order to learn whether a new compound (ACC-001 with an adjuvant) is safe, acts like a vaccine and has an effect on patient mental performance.

A phase II a , Multicenter, Randomized , Third -party Unblinded , Long- term Extension study to Determine Safety, Tolerability and Immunogenicity of ACC-001 with QS-21 Adjuvant in Subjects with Mild to Moderate Alzheimer's Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010922-21-DE

Enrollment

120

Registered

2009-06-12

Start date

2009-09-18

Completion date

Unknown

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with mild to moderate Alzheimer's disease. MedDRA version: 14.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: ACC-001 Product Code: ACC-001 Pharmaceutical Form: Solution for injection Current Sponsor code: ACC-001 (PF-05236806) Other descriptive name: A-Beta-1-7-CRM197 Conjugate Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects were randomized under previous 3134K1-200-EU study and met all inclusion and none of the exclusion criteria. 2. Subject must have completed through week 78 of study 3134K1-200-EU and received at least 3 doses of investigational product and has been compliant in the opinion of the investigator and sponsor. 3. Screening brain MRI scan is consistent with the diagnosis of AD. 4. Mini-Mental State Examination (MMSE) score >=10. 5. Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately 5 times per week for the duration of the study. 6. In the opinion of the investigator, the subject and the caregiver will be compliant and have a high probability of completing the study. 7. The subject and caregiver are likely to be able to participate in all scheduled examinations and complete all required tests. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 52

Exclusion criteria

Exclusion criteria: 1. Significant neurological disease other than AD that may affect cognition or function. 2. Early termination (ET) from the preceding 3134K1 200-EU study. 3. Experienced a SAE in the preceding double-blind study deemed related to investigational product. 4. Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200-EU study. 5. History of screening visit brain MRI scan indicative of any other significant abnormality including but not limited to more than 4 microhemorrhages ( 1 cm3, multiple lacunar infarcts (2 or more) or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or spaceoccupying lesions (eg, arachnoid cysts or brain tumors, such as meningioma). 6. Current clinically important systemic illness that is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study. 7. Current presence of a clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition-Text Revision (DSM-IV-TR), or symptom (e.g.,hallucinations, suicidal ideation, suicidal behavior), that could affect the subject's ability to complete the study. 8. Other clinically significant abnormality on screening visit which includes physical, neurological, laboratory, or electrocardiogram (ECG) examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject. 9. Current use of clopidogrel (Plavix) and central nervous system (CNS) stimulants eg, methylphenidate [Ritalin]). 10. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, cerebrospinal fluid (CSF) shunts, or metal fragments or foreign objects in the eyes, skin, or body, or claustrophobia that would contraindicate a brain MRI scan.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of doses of 3, 10, and 30 µg of ACC-001 (CRM-conjugated A-beta [1-7] antigen in combination with QS-21 adjuvant) in subjects with mild to moderate AD.;Secondary Objective: No secondary objectives in study only Exploratory objectives: • To assess the immunogenicity of doses of 3, 10, and 30 µg of ACC-001 in combination with QS-21. • To assess the long-term efficacy of ACC-001 in subjects with mild to moderate AD. • To evaluate the effect of ACC-001 on patient quality of life (QoL) and caregiver dependence and related health outcomes. • To compare the efficacy at the end of the study between those subjects who received ACC-001 with or without QS-21 in the preceding double-blind trial and those subjects who received phosphate-buffered saline (PBS) or QS-21 in the preceding trial. • To evaluate the change from baseline volumes for whole brain volume, brain boundary shift integral (BBSI), ventricular volume, hippocampal boundary shift integral (HBSI) and ventricular boundary shift integral (BSI) as assessed from MRI scans. • To evaluate the change from baseline of A-beta, total tau, and phosphorylated tau (p-tau) in cerebrospinal fluid at week 78.;Primary end point(s): Safety assessments will include vital sign measurements, weight, physical and neurological examinations, 12-lead ECG recordings, and brain MRI scans (at screening and before each immunization and at the end of the study), including T2*/gradient echo MRI). Clinical laboratory evaluations will include complete blood count (CBC) with platelet count, chemistry panel, and urinalysis, thyroid panel, serum vitamin B12 and folate, coagulation studies, and circulating immune complexes and anti-A-beta titers. ;Timepoint(s) of evaluation of this end point: At every study visit	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of doses of 3, 10, and 30 µg of ACC-001 (CRM-conjugated A-beta [1-7] antigen in combination with QS-21 adjuvant) in subjects with mild to moderate AD.;Secondary Objective: No secondary objectives in study only Exploratory objectives: • To assess the immunogenicity of doses of 3, 10, and 30 µg of ACC-001 in combination with QS-21. • To assess the long-term efficacy of ACC-001 in subjects with mild to moderate AD. • To evaluate the effect of ACC-001 on patient quality of life (QoL) and caregiver dependence and related health outcomes. • To compare the efficacy at the end of the study between those subjects who received ACC-001 with or without QS-21 in the preceding double-blind trial and those subjects who received phosphate-buffered saline (PBS) or QS-21 in the preceding trial. • To evaluate the change from baseline volumes for whole brain volume, brain boundary shift integral (BBSI), ventricular volume, hippocampal boundary shift integral (HBSI) and ventricular boundary shift integral (BSI) as assessed from MRI scans. • To evaluate the change from baseline of A-beta, total tau, and phosphorylated tau (p-tau) in cerebrospinal fluid at week 78.;Primary end point(s): Safety assessments will include vital sign measurements, weight, physical and neurological examinations, 12-lead ECG recordings, and brain MRI scans (at screening and before each immunization and at the end of the study), including T2*/gradient echo MRI). Clinical laboratory evaluations will include complete blood count (CBC) with platelet count, chemistry panel, and urinalysis, thyroid panel, serum vitamin B12 and folate, coagulation studies, and circulating immune complexes and anti-A-beta titers. ;Timepoint(s) of evaluation of this end point: At every study visit

—

Secondary

Measure	Time frame
Secondary end point(s): No secondary endpoints in study - exporataory endpoints are: To assess the immunogenicity of doses of 3, 10, and 30 ug of ACC-001 (CRM-conjugated A-beta [1-7] antigen in combination with QS-21 adjuvant) in subjects with mild to moderate AD. Change from baseline levels of anti-A-beta IgG at week 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104. baseline is defined as level prior to first treatment with ACC-001 with QS 21. Anti-A-beta IgM and IgG subclass antibody levels may be assessed at selected time points. ? To assess the long-term efficacy of ACC-001 in subjects with mild to moderate AD utilizing Alzheimer disease assessment scale-cognitive (ADAS-Cog), mini-mental state examination (MMSE), neuropsychiatric test battery (NTB), disability assessment for dementia (DAD), neuropsychiatric inventory (NPI), and clinical dementia rating-sum of boxes (CDR-SOB) at week 0, 26, 52, 78, and 104. ? To evaluate the health outcomes of times spent caregiving and resource utilization (Resource Use Dementia [RUD-lite]), quality of life in patients with AD [QoL-AD], and Dependence Scale (DS) at week 0, 26, 52, 78, and 104 To compare the efficacy at the end of the study between those subjects who received ACC-001in the preceding double-blind trial and those subjects who received placebo (phosphate-buffered saline [PBS] or QS-21) in the preceding trial. ? To evaluate the change from baseline volumes for whole brain volume, brain boundary shift integral (BBSI), hippocampal boundary shift integral (HBSI), ventricular volume, and ventricular boundary shift integral (VBSI) as assessed from MRI scans, at month 24 –(week 104). ? To evaluate the change from baseline of A-beta, total tau, and phosphorylated tau (p-tau) in cerebrospinal fluid at week 78.;Timepoint(s) of evaluation of this end point: At various timepoint between Day 1 and Week 104	—

Measure

Time frame

Secondary end point(s): No secondary endpoints in study - exporataory endpoints are: To assess the immunogenicity of doses of 3, 10, and 30 ug of ACC-001 (CRM-conjugated A-beta [1-7] antigen in combination with QS-21 adjuvant) in subjects with mild to moderate AD. Change from baseline levels of anti-A-beta IgG at week 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104. baseline is defined as level prior to first treatment with ACC-001 with QS 21. Anti-A-beta IgM and IgG subclass antibody levels may be assessed at selected time points. ? To assess the long-term efficacy of ACC-001 in subjects with mild to moderate AD utilizing Alzheimer disease assessment scale-cognitive (ADAS-Cog), mini-mental state examination (MMSE), neuropsychiatric test battery (NTB), disability assessment for dementia (DAD), neuropsychiatric inventory (NPI), and clinical dementia rating-sum of boxes (CDR-SOB) at week 0, 26, 52, 78, and 104. ? To evaluate the health outcomes of times spent caregiving and resource utilization (Resource Use Dementia [RUD-lite]), quality of life in patients with AD [QoL-AD], and Dependence Scale (DS) at week 0, 26, 52, 78, and 104 To compare the efficacy at the end of the study between those subjects who received ACC-001in the preceding double-blind trial and those subjects who received placebo (phosphate-buffered saline [PBS] or QS-21) in the preceding trial. ? To evaluate the change from baseline volumes for whole brain volume, brain boundary shift integral (BBSI), hippocampal boundary shift integral (HBSI), ventricular volume, and ventricular boundary shift integral (VBSI) as assessed from MRI scans, at month 24 –(week 104). ? To evaluate the change from baseline of A-beta, total tau, and phosphorylated tau (p-tau) in cerebrospinal fluid at week 78.;Timepoint(s) of evaluation of this end point: At various timepoint between Day 1 and Week 104

—

Countries

France, Germany, Spain

Contacts

Public ContactClinical Trials.gov Call Centre

Pfizer Inc

ClinicalTrials.gov_Inquiries@pfizer.com+18007181021

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026