Alzheimer's DiseasePhase 1NCT01406145
A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of Donepezil
A Phase 1 study testing ASP0777 in people with Alzheimer's Disease, run by Astellas Pharma Inc at 2 sites in United States.
Trial summary
This study is intended to determine the safety and tolerability of ASP0777 in subjects with Alzheimer's Disease (AD) taking a stable dose of donepezil. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ASP0777
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jun 2011to 4 Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a Mini-Mental Status Exam score of 18-26
- Subject has a diagnosis of "probable" Alzheimer's Disease
- Subject has used donepezil for at least 3 months and has been on a stable dose for at least 6 weeks prior to screening
- Subject has a reliable adult who is residing with him/her during the outpatient portion of the study
- Subject is medically stable
- Subject has adequate cognitive, hearing, vision, and language skills
- Subject is able to ingest oral tablets
Who cannot join
- Subject has received any investigational product in another clinical study or post-marketing clinical study within past 3 months
- Subject has any clinically significant abnormal laboratory tests
- Subject is a female who is pregnant, lactating or of childbearing potential who refuses to use a form of contraception during the study
- Subject has a history of a drug allergy or intolerance to memantine or a related compound
- Subject is currently using anti-dementia drugs (except for donepezil) or has used any such drugs within the last 4 weeks
- Subject has a score of 2 on item 16 of Cornell Scale for Depression in Dementia (CSDD) or has an overall CSDD score > 10
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- Subject is using off-label medicines, non-medicinal compounds, or dietary aids/food supplements to improve cognition that have not been at a stable dose for at least 4 weeks prior to Screening and/or are anticipated to change dosing regimen during the study
- Subject has a history of drug or alcohol abuse within the past 12 months or subject consumes > 1 drink of alcohol daily, or is unable to refrain from alcohol during the study
- Subject is a current smoker or recently quit smoking (within the past 12 months)
- Subject has a clinically significant medical condition that is unstable or is likely to become unstable during the course of the study
- Subject has history of seizures, other than febrile seizures during infancy
- Subject has history of repeated falls within past 6 months
- Subject has a major psychiatric illness or has received treatment for symptoms of a major psychiatric illness within past 1 year. Mild psychiatric disorders are allowable
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Clinical
Hallandale, Florida, 33009
Pacific Research Network, Inc.
San Diego, California, 92103
About this study
Official title: A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Sequential Dose Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease on Donepezil
This study is intended to determine the safety and tolerability of ASP0777 in subjects with Alzheimer's Disease (AD) taking a stable dose of donepezil.
- Conditions
- Alzheimer's Disease
- Being tested
- ASP0777, Placebo
- Keywords
- ASP0777, Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP0777Drug
oral tablet
PlaceboDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| ASP0777 low dose | Experimental | ASP0777 low dose for 6 weeks Receives: Drug: ASP0777 |
| ASP0777 low dose, then high dose | Experimental | ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks Receives: Drug: ASP0777 |
| ASP0777 high dose | Experimental | ASP0777 high dose for 6 weeks Receives: Drug: ASP0777 |
| Placebo | Placebo comparator | Placebo for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with adverse events
Measured: Up to 56 Days
Secondary outcomes (1)
Pharmacokinetic assessment of AUC, maximum concentration (Cmax), minimum concentration (Cmin) and time to maximum concentration (tmax) through analysis of blood samples
Measured: Up to 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study start16 Jun 2011
- Primary completion4 Nov 2011
- Study completion4 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406145
- Sponsor's protocol ID
- 0777-CL-0030
- Status last verified
- Oct 2024
- First submitted
- 6 Jul 2011
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Sequential Dose Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease on Donepezil
- ClinicalTrials.gov ID
- NCT01406145
- Acronym / sponsor ID
- 0777-CL-0030
- Conditions
- Alzheimer's Disease
- Keywords
- ASP0777, Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2011 (actual)
- Primary completion
- 4 Nov 2011 (actual)
- Study completion
- 4 Nov 2011 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to determine the safety and tolerability of ASP0777 in subjects with Alzheimer's Disease (AD) taking a stable dose of donepezil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP0777 low dose | Experimental | Drug: ASP0777ASP0777 low dose for 6 weeks |
| ASP0777 low dose, then high dose | Experimental | Drug: ASP0777ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks |
| ASP0777 high dose | Experimental | Drug: ASP0777ASP0777 high dose for 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 6 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has a Mini-Mental Status Exam score of 18-26
- Subject has a diagnosis of "probable" Alzheimer's Disease
- Subject has used donepezil for at least 3 months and has been on a stable dose for at least 6 weeks prior to screening
- Subject has a reliable adult who is residing with him/her during the outpatient portion of the study
- Subject is medically stable
Key exclusion criteria (13 listed)
- Subject has received any investigational product in another clinical study or post-marketing clinical study within past 3 months
- Subject has any clinically significant abnormal laboratory tests
- Subject is a female who is pregnant, lactating or of childbearing potential who refuses to use a form of contraception during the study
- Subject has a history of a drug allergy or intolerance to memantine or a related compound
- Subject is currently using anti-dementia drugs (except for donepezil) or has used any such drugs within the last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP0777oral tablet | Drug | ASP0777 high dose, ASP0777 low dose, ASP0777 low dose, then high dose |
| Placebooral tablet | Drug | Placebo |
Primary outcome
Number and percentage of subjects with adverse events
Time frame: Up to 56 Days
1 secondary outcome
Pharmacokinetic assessment of AUC, maximum concentration (Cmax), minimum concentration (Cmin) and time to maximum concentration (tmax) through analysis of blood samples
Time frame: Up to 56 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP0777 in people with Alzheimer's Disease, run by Astellas Pharma Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of subjects with adverse events (time frame: Up to 56 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.