Alzheimer DiseasePhase 1PharmacogWP3NCT01487395
Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development
A Phase 1 study testing Donepezil . in people with Alzheimer Disease and Battery, run by University Hospital, Lille at 3 sites in France.
Trial summary
The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Battery
- What is being tested?
- Donepezil .
- 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
- 3 sitesFrance
- Study dates
- Dec 2011to Dec 2013
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 year old male non-smoker subjects
- Subject without cognitive impairment or cognitive complaint (Moca>26, Mac Nair scale<15)
- Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,…)
- Subject without major medical or surgical history
- Subject without current chronic disease
- Subject without current cerebral disease
Show all 12Show fewer
- Subject without vascular or metabolic risk factor
- Subject without history or current mental disease or addiction (MINI)
- Subject without lesion on MRI
- Subject without abnormal electrical activities on EEG
- Subject without use of chronic treatment or psychotropic drugs or substances
- French speaker subject and able to understand the test instructions
Who cannot join
- Subject with age < 18 years or > 30 years
- Subject with dementia or cognitive decline identified by Moca < 26
- Subject with history of brain disease (brain trauma, stroke, cerebral tumor,…)
- Subject with major medical or surgical history
- Subject with current chronic disease
- Subject with current cerebral disease
Show all 16Show fewer
- Subject with vascular or metabolic risk factor
- Subject with history or current mental disease or addiction
- Subject with family history of young-onset dementia
- Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
- Subject with lesion on MRI
- Subject with abnormal electrical activities on EEG
- Subject receiving a chronic treatment
- Subject using chronically or acutely psychotropic drugs or substances
- Subject with claustrophobia or contra-indication to MRI
- Subject unable to understand the test instructions
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Lille/ Centre d'investigation Clinique
Lille, 59037
CIC Marseille
Marseille
CIC Toulouse
Toulouse
About this study
Official title: Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers
The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs
Read the detailed description
The aim of the present study is to test the effect of a 15-day treatment with donepezil on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers.
This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).
18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters.
- Conditions
- Alzheimer Disease, Battery
- Being tested
- Donepezil ., Placebo
- Keywords
- Alzheimer, Donepezil, biomarkers, battery, cognition, imaging, neurophysiological
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil .Drug
Also called ARICEPT ® Donépezil, Orally Disintegrating Tablets (ODT): 5 mg.
Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
PlaceboDrug
the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Active comparator | Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days. Receives: Drug: Donepezil . |
| Placebo | Placebo comparator | The placebo will be presented as tablet comparable to ARICEPT Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacog battery
- cognitive tests (8 items of the Cantab battery) :
- Motor screening
- 4 tests for visual memory (Delayed Matching to Sample, Paired Associated Learning, Pattern Recognition Memory, Spatial Recognition Memory)
- 1 test for executive functions (Spatial Working Memory)
- 2 tests for attention (Reaction Time, Rapid Visual Information Processing)
- completed by a modified ADNI battery : ADAScog
- imaging
- fMRI
- PET-FDG
- neurophysiological
- EEG
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2013
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.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medicines Initiative
- Responsible party
- Sponsor
- Investigators
- Régis Bordet, MD PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487395
- Sponsor's protocol ID
- 2010_41
- Other IDs
- 2010-023989-51
- Acronym
- PharmacogWP3
- Status last verified
- Apr 2015
- First submitted
- 5 Dec 2011
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01487395
- Acronym / sponsor ID
- PharmacogWP3 / 2010_41
- Conditions
- Alzheimer Disease, Battery
- Keywords
- Alzheimer, Donepezil, biomarkers, battery, cognition, imaging, neurophysiological
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Innovative Medicines Initiative
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Dec 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.
The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs
Detailed description
The aim of the present study is to test the effect of a 15-day treatment with donepezil on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers.
This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).
18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil | Active comparator | Drug: Donepezil .Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo will be presented as tablet comparable to ARICEPT |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 18-30 year old male non-smoker subjects
- Subject without cognitive impairment or cognitive complaint (Moca>26, Mac Nair scale<15)
- Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,…)
- Subject without major medical or surgical history
- Subject without current chronic disease
Key exclusion criteria (16 listed)
- Subject with age < 18 years or > 30 years
- Subject with dementia or cognitive decline identified by Moca < 26
- Subject with history of brain disease (brain trauma, stroke, cerebral tumor,…)
- Subject with major medical or surgical history
- Subject with current chronic disease
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 |
|---|---|---|
| Donepezil .Also: ARICEPT ® Donépezil, Orally Disintegrating Tablets (ODT): 5 mg.Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days. | Drug | Donepezil |
| Placebothe placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days. | Drug | Placebo |
Primary outcome
Pharmacog battery
Time frame: 15 days
* cognitive tests (8 items of the Cantab battery) : * Motor screening * 4 tests for visual memory (Delayed Matching to Sample, Paired Associated Learning, Pattern Recognition Memory, Spatial Recognition Memory) * 1 test for executive functions (Spatial Working Memory) * 2 tests for attention (Reaction Time, Rapid Visual Information Processing) * completed by a modified ADNI battery : ADAScog * imaging * fMRI * PET-FDG * neurophysiological * EEG
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 9 Apr 2015.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Régis Bordet, MD PhD principal investigator
University Hospital, Lille
3 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 Donepezil . in people with Alzheimer Disease and Battery, run by University Hospital, Lille at 3 sites in France.
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 12 inclusion and 16 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 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Pharmacog battery (time frame: 15 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 9 Apr 2015.