DementiaPhase 2/3NCT00503516
Study to Evaluate the Effect of Megestrol Acetate in Weight Loss in Dementia Patients
A Phase 2/3 study testing Megestrol acetate in people with Dementia, run by Rottapharm Spain at 1 site in Spain.
Trial summary
The purpose of this study is to demonstrate the efficacy of megestrol acetate in the gain of body weight in patients with primary or mixed Dementia with a weight loss. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Dementia
- What is being tested?
- Megestrol acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2007to Feb 2010
- Phase
- Phase 2/3
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients diagnosed of primary or mixed dementia (CIE 10criteria)
- Weihgt loss >5% of habitual weight in the last 6 months and proteic-caloric malnutrition (MNA <17)
- Outpatients
- Patients that accept the participation in the study
Who cannot join
- Vascular pure Dementia and secondary dementias( vascular dementia, Parkinson disease,etc)
- Dementia in a terminal phase: category of FAST 7c in the Reisber scale
- Concomitant treatment with steroids, androgens or other drugs with progestagens
- Weight loss secondary to neoplasia
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Socio Sanitario del Hospitalet
El Hospitalet, Barcelona, 08906
About this study
Official title: Multicenter, Double Blind, Randomized, Clinical Trial, Controlled With Placebo, to Evaluate the Effect of the Treatment With 320 mg/Day of Megestrol Acetate During 24 Weeks in the Weight Loss in Mixed Dementia Patients.
The purpose of this study is to demonstrate the efficacy of megestrol acetate in the gain of body weight in patients with primary or mixed Dementia with a weight loss.
Read the detailed description
In all geriatric patients with dementia it was prove a weight loss independently if they are institutionalized or not.There are some previous studies that indicates the effect of the megestrol acetate in the weight gain of patients with cachexia-anorexia related with neoplasia. It seems that the mechanism of development could be the same between these patients and patients with dementia. It was described an important role of a group of cytokines ( Il-6, leptin, neuropeptide Y, TNFalfa) in the development of this nutritional alteration.
Some previous pilots studies indicates that megestrol acetate has and effect in geriatric and dementia patients with a weight loss of at least 5% in the last 6 months.
- Conditions
- Dementia
- Being tested
- Megestrol acetate, Placebo
- Keywords
- weight loss, appetite, dementia, megestrol acetate
- Medical subject headings
- Dementia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol acetateDrug
1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks
PlaceboDrug
1 sachet of 160 mg of placebo b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Megestrol acetate 160 mg b.i.d. during 24 weeks Receives: Drug: Megestrol acetate |
| 2 | Placebo comparator | 1 sachet of powder of placebo b.i.d. during 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change in the body weight
Measured: 24 weeks
Secondary outcomes (5)
To evaluate the change in the appetite
Measured: 24 weeks
To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin
Measured: 24 weeks
Evaluate the change in the nutritional status (Mini-Nutritional Assessment)
Measured: 24 weeks
To evaluate the change in cognitive state ( Mini-Mental State Examination)
Measured: 24 weeks
To evaluate the safety of the treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionFeb 2010
Why it stopped: Difficulties to recruit the patients following the inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pau Sánchez, MD, Study chair, Hospital Socio Sanitario del Hospitalet (Barcelona)Salvador Altimir, MD, Principal investigator, Hospital Universitari Germans Trias i Pujol (Badalona)Ramón Cristófol, MD, Principal investigator, Antic Hospital Sant Jaume i Santa Magdalena (Mataró)Olga Sabartés, MD, Principal investigator, Hospital del MarEnrique Arriola, MD, Principal investigator, Fundación Matia (San Sebastián)José Luis González, MD, Principal investigator, Hospital Nuestra Señora de la Montaña (Cáceres)Esher Martínez, MD, Principal investigator, Hospital de la Santa Creu (Tortosa)Roberto Petidier, MD, Principal investigator, Hospital Universitario de Getafe (Madrid)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503516
- Sponsor's protocol ID
- BO-EC-DEM-02
- Other IDs
- EudraCT number:2006-005759-13
- Status last verified
- Jun 2011
- First submitted
- 17 Jul 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double Blind, Randomized, Clinical Trial, Controlled With Placebo, to Evaluate the Effect of the Treatment With 320 mg/Day of Megestrol Acetate During 24 Weeks in the Weight Loss in Mixed Dementia Patients.
- ClinicalTrials.gov ID
- NCT00503516
- Acronym / sponsor ID
- BO-EC-DEM-02
- Conditions
- Dementia
- Keywords
- weight loss, appetite, dementia, megestrol acetate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties to recruit the patients following the inclusion criteria
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Rottapharm SpainIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Jul 2007 (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 purpose of this study is to demonstrate the efficacy of megestrol acetate in the gain of body weight in patients with primary or mixed Dementia with a weight loss.
Detailed description
In all geriatric patients with dementia it was prove a weight loss independently if they are institutionalized or not.There are some previous studies that indicates the effect of the megestrol acetate in the weight gain of patients with cachexia-anorexia related with neoplasia. It seems that the mechanism of development could be the same between these patients and patients with dementia. It was described an important role of a group of cytokines ( Il-6, leptin, neuropeptide Y, TNFalfa) in the development of this nutritional alteration.
Some previous pilots studies indicates that megestrol acetate has and effect in geriatric and dementia patients with a weight loss of at least 5% in the last 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Megestrol acetateMegestrol acetate 160 mg b.i.d. during 24 weeks |
| 2 | Placebo comparator | Drug: Placebo1 sachet of powder of placebo b.i.d. during 24 weeks |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed of primary or mixed dementia (CIE 10criteria)
- Weihgt loss >5% of habitual weight in the last 6 months and proteic-caloric malnutrition (MNA <17)
- Outpatients
- Patients that accept the participation in the study
Key exclusion criteria (4 listed)
- Vascular pure Dementia and secondary dementias( vascular dementia, Parkinson disease,etc)
- Dementia in a terminal phase: category of FAST 7c in the Reisber scale
- Concomitant treatment with steroids, androgens or other drugs with progestagens
- Weight loss secondary to neoplasia
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 |
|---|---|---|
| Megestrol acetate1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks | Drug | 1 |
| Placebo1 sachet of 160 mg of placebo b.i.d. | Drug | 2 |
Primary outcome
To evaluate the change in the body weight
Time frame: 24 weeks
5 secondary outcomes
To evaluate the change in the appetite
Time frame: 24 weeks
To evaluate the change in biochemical markers: Il-6, Il-1, leptin, TNFalfa, neuropeptide Y, albumin and prealbumin
Time frame: 24 weeks
Evaluate the change in the nutritional status (Mini-Nutritional Assessment)
Time frame: 24 weeks
To evaluate the change in cognitive state ( Mini-Mental State Examination)
Time frame: 24 weeks
To evaluate the safety of the treatment
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Difficulties to recruit the patients following the inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
Pau Sánchez, MD study chair
Hospital Socio Sanitario del Hospitalet (Barcelona)
Salvador Altimir, MD principal investigator
Hospital Universitari Germans Trias i Pujol (Badalona)
Ramón Cristófol, MD principal investigator
Antic Hospital Sant Jaume i Santa Magdalena (Mataró)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Megestrol acetate in people with Dementia, run by Rottapharm Spain 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Jun 2011. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Difficulties to recruit the patients following the inclusion criteria). 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?
To evaluate the change in the body weight (time frame: 24 weeks). 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 8 Jun 2011.