Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02991235

Enrollment

Registered

2016-12-13

Start date

2016-12-31

Completion date

2018-12-31

Last updated

2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

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).

Interventions

DIETARY_SUPPLEMENTPRJ212

6 capsules of study product will be taken daily and orally.

DIETARY_SUPPLEMENTPlacebo

6 capsules of study product will be taken daily and orally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	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 memory composite (R-BANS+WMS).	Comparison of the total memory composite 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026