Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRJ212 | Experimental | PRJ212 is a nutritional product with active food ingredients. |
|
| Placebo | Placebo Comparator | Placebo is like PRJ212 without active food ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRJ212 | Dietary Supplement | 6 capsules of study product will be taken daily and orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS). | 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). | 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). | Comparison of the total memory composite score, from baseline to 6 months. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martinez | Bioiberica, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació ACE | Barcelona | 08028 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
6 capsules of study product will be taken daily and orally. |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |