Study on the effects of a natural food supplement on memory and daily function in people with mild to moderate Alzheimer's disease

ISRCTN	ISRCTN11405046
DOI	https://doi.org/10.1186/ISRCTN11405046
Sponsor	Pharmaceutica San Marco
Funder	Pharmaceutica San Marco

Submission date: 01/07/2026
Registration date: 01/07/2026
Last edited: 30/07/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Maria Grazia Morgese
Scientific

via napoli 121
Foggia
71122
Italy

ORCID ID	0000-0002-9887-5504
Phone	+39 881338852
Email	mariagrazia.morgese@unifg.it

Prof Luigia Trabace
Scientific, Public

via Napoli 121
Foggia
71122
Italy

Phone	+39 881338856
Email	luigia.trabace@unifg.it

Dr Carmen Ritrovato
Principal investigator

Territorial Health Center - San Marco in Lamis -Contrada Pozzo Zolfo, San Marco in Lamis
Foggia
71104
Italy

Phone	+39 882815615
Email	carmen.ritrovato@aslfg.it

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Prevention, Supportive care
Scientific title	Nutraceutics in Alzheimer's disease
Study acronym	NAD
Study objectives	The aim of this interventional study is to evaluate the effect of these nutraceutical compounds on the cognitive performance of a cohort of patients with mild-to-moderate Alzheimer's disease. Given the extensive neurological damage caused by Alzheimer's disease, our nutraceutical formulation, which is safe and composed of naturally occurring compounds with neurotrophic and anti-inflammatory properties, may help preserve the integrity of the extracellular matrix, modulate the production of pro-inflammatory cytokines, prevent neuronal degeneration, improve neurological function—particularly cognitive impairment, memory deficits, and depressive symptoms—and potentially delay disease onset and slow its progression.
Ethics approval(s)	Approved 15/05/2023, Interprovincial Ethics Committee – Area 1, Apulia, Italy (c/o Ospedali Riuniti di Foggia-Via Pinto 71122, Foggia, 71122, Italy; +39 881 732464; segreteriacomitatoetico@ospedaliriunitifoggia.it), ref: 88/CE/2023
Health condition(s) or problem(s) studied	Mild cognitive impairment, early dementia
Intervention	Clove (Syzygium aromaticum) liquid extract: 42 mg/day, of which beta-caryophyllene 37.8 mg, terpenes 4.2 mg - Myrrh liquid extract: 24 mg/day, of which furanodienes 19.2 mg, terpenes 4.8 mg - Boswellia serrata powder: 42 mg/day, of which boswellic acids 27.3 mg, amyrins 8.4 mg - Microalgae oil extract: 1,853 mL/day, titrated 550 mg in DHA (1000 mg/day) and 3.1 mg in EPA (5.7 mg/day) - Flavoring: lemon and sweet orange essential oils The placebo consisted of: edible linseed oil, flavoring (lemon and sweet orange essential oils) as above. Patients were equally allocated to the two arms according to randomization Duration is 6 months
Intervention type	Supplement
Primary outcome measure(s)	Psychometric assessments measured using Clinical Dementia Rating (CDR) at baseline, 3 months, 6 months Psychometric assessment measured using mini mental state examination (MMSE) at baseline, 3 months, 6 months
Key secondary outcome measure(s)	Depressive state measured using Zung score at baseline, 3 months, 6 months Neurodegenerative biomarkers measured using light neurofilaments -ELISA method at baseline, 3 months, 6 months Neurodegenerative biomarkers measured using amyloid beta-ELISA method at baseline, 3 months, 6 months Neurodegenerative biomarkers measured using pTAU-ELISA method at baseline, 3 months, 6 months
Completion date	21/08/2024

Eligibility

Participant type(s)
Age group	Senior
Lower age limit	65 Years
Upper age limit	85 Years
Sex	All
Target sample size at registration	54
Total final enrolment	46
Key inclusion criteria	Patients aged 65–85 years with cognitive impairment ranging from mild cognitive impairment to mild/moderate dementia, as assessed by the Clinical Dementia Rating (CDR) scale (scores 0.5–2)
Key exclusion criteria	1. CDR scores <0.5 or >2 2. Recent stroke or transient ischemic attack 3. Unstable heart disease 4. Renal and hepatic failure 5. Oncologic patients 6. Inability to provide consent or refusing to provide informed consent
Date of first enrolment	18/07/2023
Date of final enrolment	21/06/2024

Locations

Countries of recruitment

Italy

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		28/07/2026	30/07/2026	Yes	No

Editorial Notes

30/07/2026: Publication reference added.
02/07/2026: Contact details updated.
01/07/2026: Trial's existence confirmed by Interprovincial Ethics Committee – Area 1, Apulia, Italy.