Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
12. desember 2014 oppdatert av: Pfizer
A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
53
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Osaka, Japan, 530-8480
- Tazuke Kofukai Medical Research Institute Kitano Hospital
-
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Aichi
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Nagoya, Aichi, Japan, 451-8511
- Meitetsu Hospital
-
-
Ibaraki
-
Kasama, Ibaraki, Japan, 309-1793
- Ibaraki Prefectural Central Hospital
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-
Kanagawa
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Atsugi, Kanagawa, Japan, 243-8551
- Shonan Atsugi Hospital
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Sagamihara-shi, Kanagawa, Japan, 252-0380
- Kitasato University East Hospital
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-
Nagano
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Suwa, Nagano, Japan, 392-8510
- Suwa Red Cross Hospital
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Osaka
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Takatsuki, Osaka, Japan, 569-8686
- Osaka Medical College Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Koto-ku, Tokyo, Japan, 136-0075
- Juntendo Tokyo Koto Geriatric Medical Center
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Minato-ku, Tokyo, Japan, 105-8471
- The Tokyo Jikei University School of Medicine
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Setagaya-ku, Tokyo, Japan, 158-8531
- Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
52 år til 87 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
- Screening brain MRI scan is consistent with the diagnosis of AD.
- MMSE score 10 and above.
Exclusion Criteria:
- Significant neurological diseases other than AD.
- Brain MRI evidence of vasogenic edema during the preceding studies.
- Clinically significant illness.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ACC-001 (3 micrograms) + QS-21
Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
|
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
|
|
Eksperimentell: ACC-001 (10 micrograms) + QS-21
Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
|
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
|
|
Eksperimentell: ACC-001 (30 micrograms) + QS-21
Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
|
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Treatment Emergent Adverse Events (AEs) by Severity
Tidsramme: Baseline up to 24 months
|
Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
|
Baseline up to 24 months
|
|
Antall deltakere med hjerneabnormiteter i data for magnetisk resonansavbildning (MRI).
Tidsramme: Baseline opptil 24 måneder
|
Antall deltakere med hjerneabnormiteter i MR-data som enten er konsistente eller ikke konsistente med AD, bestemt av radiologer.
|
Baseline opptil 24 måneder
|
|
Number of Participants With Abnormalities in Neurological Examination
Tidsramme: Baseline of the preceding studies through 24 months of this study
|
Number of participants with abnormalities in neurological examinations as determined by the investigators.
Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
|
Baseline of the preceding studies through 24 months of this study
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
Tidsramme: Baseline of preceding studies to month 24 of this study (Week 210)
|
Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study
|
Baseline of preceding studies to month 24 of this study (Week 210)
|
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Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
Tidsramme: Baseline of preceding studies to month 24 of this study (Week 210)
|
Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study
|
Baseline of preceding studies to month 24 of this study (Week 210)
|
|
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.
Tidsramme: Baseline up to 24 Months
|
The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility.
For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment.
The total score ranges from 0 (no impairment) to 70 (worst impairment).
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Baseline up to 24 Months
|
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The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.
Tidsramme: Baseline up to 24 Months
|
The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.
A total score is obtained by adding the rating for each question and converting this total score out of 100.
Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
|
Baseline up to 24 Months
|
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The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.
Tidsramme: Baseline up to 24 Months
|
The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function.
The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test.
The NTB z-score is used for analysis.
The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.
|
Baseline up to 24 Months
|
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The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.
Tidsramme: Baseline up to 24 Months
|
The MMSE is a brief, structured examination of cognitive function.
It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.
|
Baseline up to 24 Months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2010
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. desember 2013
Datoer for studieregistrering
Først innsendt
21. oktober 2010
Først innsendt som oppfylte QC-kriteriene
9. november 2010
Først lagt ut (Anslag)
11. november 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B2571001
- 3134K1-2207 (Annen identifikator: Alias Study Number)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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