Alzheimer DiseaseNCT02991235
Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease
A study testing PRJ212 in people with Alzheimer Disease, run by Bioiberica at 1 site in Spain.
Trial summary
A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- PRJ212
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2016to Dec 2018
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 60 to 85 years.
- Patients with a diagnosis of probable or possible Alzheimer's disease according to the NINCDS-ADRDA.
- Patients with mild Alzheimer's disease according to MMSE.
- Patients with ability to ingest oral medication.
- Patients able to undergo a MRI.
Who cannot join
- Pregnant or breastfeeding women or planning a pregnancy during the study.
- Patients and caregivers unwilling or unable to perform cognitive testing.
- Patients taking part in an interventional clinical trial.
- Patients who have a risk of non-compliance to the study procedures.
- Patients with clinical or significant laboratory abnormalities.
- Patients treated with concomitant treatment or food supplements which could interfere with evaluation criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of PRJ212 on Improving the Memory of Patients With Mild Severity Alzheimer's Disease: A 6-month Randomized, Double-blind and Placebo-controlled, Followed by a 6-month Open Label Extension Study
A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.
Read the detailed description
Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease, according to the diagnostic criteria established by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA).
- Conditions
- Alzheimer Disease
- Being tested
- PRJ212, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRJ212Dietary supplement
6 capsules of study product will be taken daily and orally.
PlaceboDietary supplement
6 capsules of study product will be taken daily and orally.
| Study group | Role | What they receive |
|---|---|---|
| PRJ212 | Experimental | PRJ212 is a nutritional product with active food ingredients. Receives: Dietary Supplement: PRJ212 |
| Placebo | Placebo comparator | Placebo is like PRJ212 without active food ingredients. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).
Measured: Comparison of the R-BANS score, from baseline to 6 months.
Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).
Measured: Comparison of the WMS score, from baseline to 6 months.
Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS).
Measured: Comparison of the total memory composite score, from baseline to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martinez, Study director, Bioiberica, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991235
- Sponsor's protocol ID
- BIO-PRJ-2015-01
- Status last verified
- Jan 2018
- First submitted
- 29 Nov 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of PRJ212 on Improving the Memory of Patients With Mild Severity Alzheimer's Disease: A 6-month Randomized, Double-blind and Placebo-controlled, Followed by a 6-month Open Label Extension Study
- ClinicalTrials.gov ID
- NCT02991235
- Acronym / sponsor ID
- BIO-PRJ-2015-01
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Dec 2016 (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.
A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.
Detailed description
Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease, according to the diagnostic criteria established by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRJ212 | Experimental | Dietary Supplement: PRJ212PRJ212 is a nutritional product with active food ingredients. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo is like PRJ212 without active food ingredients. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged from 60 to 85 years.
- Patients with a diagnosis of probable or possible Alzheimer's disease according to the NINCDS-ADRDA.
- Patients with mild Alzheimer's disease according to MMSE.
- Patients with ability to ingest oral medication.
- Patients able to undergo a MRI.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women or planning a pregnancy during the study.
- Patients and caregivers unwilling or unable to perform cognitive testing.
- Patients taking part in an interventional clinical trial.
- Patients who have a risk of non-compliance to the study procedures.
- Patients with clinical or significant laboratory abnormalities.
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 |
|---|---|---|
| PRJ2126 capsules of study product will be taken daily and orally. | Dietary supplement | PRJ212 |
| Placebo6 capsules of study product will be taken daily and orally. | Dietary supplement | Placebo |
Primary outcome
Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).
Time frame: Comparison of the R-BANS score, from baseline to 6 months.
Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).
Time frame: Comparison of the WMS score, from baseline to 6 months.
Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS).
Time frame: Comparison of the total memory composite score, from baseline to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Martinez study director
Bioiberica, S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRJ212 in people with Alzheimer Disease, run by Bioiberica at 1 site in Spain.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
Are results available for this study?
Results are not available in the source record.
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?
Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS). (time frame: Comparison of the R-BANS score, from baseline to 6 months.). The study lists 3 primary outcomes in all. 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 19 Jan 2018.