Authors
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Muresanu, Fior-Dafin, Jemna, Nicoleta, Jemna, Nicoleta -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2023
INTERVENTION: Previous research has found that the peptides in N‐PEP‐12 exhibit qualities similar to those seen in naturally occurring peptide growth factors, such as increasing neurite outgrowth, improving neuronal survival, and protecting against metabolic stress. This study's rationale is based on these previously documented properties that have the potential to impact the attentional performance, cognition, and mental wellbeing of middle‐aged and older healthy adults with subjective cognitive function complaints. Dietary supplement: MemoProve/Cebrium Memoprove and Cebrium are two brands of the N‐PEP‐12 peptide‐based nutritional supplement available in film‐coated pills or capsules. Control: Lactose, placebo (identical to intervention) Study Group 1: 45mg N‐PEP‐12 Study Group 2: 90mg N‐PEP‐12 Study Group 3: Placebo (Lactose) Visit 1 ‐ (Study day 0) ‐ Screening ‐ will consist of the baseline assessment ‐ demographic data and the patient's medical history and risk factors will be collected. Also, the informed consent will be signed and the patient will be randomized. Visit 2 ‐ (Study day 30) will be an efficacy evaluation. Between Visit 1, Visit 2 and Visit 3 ‐ (Study day 90) patients shall receive their treatment, based on the group they have been allocated at baseline: Placebo, 45mg N‐PEP‐12 or 90 mg N‐PEP‐12. Between Visit 3 and Visit 4 ‐ (Study day 180) the patients shall continue the treatment with the two N‐PEP‐12 groups unchanged and the initial Placebo group receiving 90 mg N‐PEP‐12. This study will be conducted under double‐blind conditions in order to keep investigators, other CONDITION: Attentional performance, cognition, and mental wellbeing of middle‐aged and older healthy adults with subjective cognitive function complaints ; Signs and Symptoms PRIMARY OUTCOME: ; The three following primary outcome variables will be measured using the Test of Attentional Performance (TAP) at 0, 30, 90 and 180 days:; 1. Alertness (phasic alertness); 2. Working Memory (difficulty level 3); 3. Divided Attention; SECONDARY OUTCOME: ; The following secondary outcome variables will be measured at 0, 30, 90 and 180 days:; 1. IQ measured using the Wechsler Adult Intelligence Scale (WAIS‐IV) ‐ Digit Span Forward, Backward (DSF, DSB); 2. Stress measured using the Perceived Stress Scale (PSS); 3. Mood measured using the Brief Mood Introspection Scale (BMIS); 4. Sleep quality measured using the Sleep Quality Scale (SQS); 5. Health‐related quality of life measured using the EuroQol EQ‐5D‐5L questionnaire; INCLUSION CRITERIA: 1. Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements 2. Aged =50 years old or =75 years old, male or female (including the boundary value) 3. Male body weight =50kg,female body weight =45kg,and 18.0 =BMI =29.9 kg/m2 4. No clinically significant cognitive impairment (MoCA > 25) 5. Self‐reported subjective cognitive complaints 6. Literacy to complete tests
Epistemonikos ID: 3db5cf47ac38cc6c7a63de3c6f1d7b1d0912a82e
First added on: Feb 20, 2024